TRI-STATE DE MEXICO, S. DE R.L. DE C.V.

210 recall(s) on record — most severe on record: Class I.

Devices registered here (1)

• Neurosurgical Nerve Locator
  Product code PDQ · Class II · Ear, Nose, Throat · 21 CFR 874.1820

Recalls & enforcement

• Class IIOngoing2026-06-11
  Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
• Class IIOngoing2026-06-10
  Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
• Class IIOngoing2026-06-08
  Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; ra
• Class IOngoing2026-06-08
  The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
• Class IOngoing2026-06-05
  Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from
• Class IIOngoing2026-05-28
  Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
• Class IIOngoing2026-05-28
  Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to inf
• Class IIOngoing2026-05-21
  The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
• Class IOngoing2026-05-15
  Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particul
• Class IOngoing2026-05-06
  The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
• Class IIOngoing2026-05-04
  During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and
• Class IIOngoing2026-04-27
  Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
• Class IIOngoing2026-04-10
  Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the sy
• Class IOngoing2026-04-10
  Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
• Class IOngoing2026-03-24
  Medline has identified the presence of particulate within the fluid path of the Manifolds.
• Class IIOngoing2026-03-19
  During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
• Class IIOngoing2026-03-16
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillu
• Class IIOngoing2026-03-16
  On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
• Class IIOngoing2026-02-27
  Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
• Class IIOngoing2026-02-27
  Unapproved design changes to the products outside of the 510(k) clearance.
• Class IOngoing2026-02-27
  Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
• Class IIOngoing2026-02-25
  The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
• Class IIOngoing2026-02-18
  There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
• Class IIOngoing2026-02-16
  Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in pa
• Class IIOngoing2026-02-13
  Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connec
• Class IIOngoing2026-02-10
  Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
• Class IIOngoing2026-01-30
  The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
• Class IIOngoing2026-01-28
  Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of
• Class IIOngoing2026-01-08
  Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood produc
• Class IIOngoing2026-01-07
  Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility as
• Class IIOngoing2026-01-07
  Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility as
• Class IIOngoing2026-01-05
  Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
• Class IIOngoing2025-12-31
  Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection
• Class IIOngoing2025-12-24
  Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
• Class IIOngoing2025-12-24
  A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway
• Class IOngoing2025-12-22
  These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or de
• Class IIOngoing2025-12-16
  Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak a
• Class IIOngoing2025-12-12
  Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
• Class IOngoing2025-11-26
  Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/
• Class IIOngoing2025-11-26
  Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
• Class IIOngoing2025-11-21
  Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respirator
• Class IIOngoing2025-11-13
  The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.
• Class IIOngoing2025-11-11
  There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.
• Class IIOngoing2025-10-27
  Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
• Class IIOngoing2025-10-27
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testi
• Class IOngoing2025-10-10
  Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Vola
• Class IIOngoing2025-10-03
  Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.
• Class IIOngoing2025-10-01
  Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
• Class IIOngoing2025-09-30
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an a
• Class IIOngoing2025-09-11
  Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
• Class IIOngoing2025-09-10
  Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
• Class IOngoing2025-08-21
  The kits contain certain lots of cannula products where the catheter may not retain its shape.
• Class IOngoing2025-08-08
  Convenience kits labeled as sterile have not gone through the sterilization process.
• Class IOngoing2025-07-31
  Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if part
• Class IOngoing2025-07-25
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class IIOngoing2025-07-23
  Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reactio
• Class IOngoing2025-07-14
  Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
• Class IIOngoing2025-07-08
  Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the
• Class IIOngoing2025-06-16
  SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access v
• Class IIOngoing2025-06-12
  Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
• Class IIOngoing2025-05-23
  Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
• Class IIOngoing2025-05-15
  There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
• Class IOngoing2025-04-22
  Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
• Class IIOngoing2025-04-09
  Three is the potential for the retractors to puncture through the sterile packaging.
• Class IIOngoing2025-03-24
  A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
• Class IIOngoing2025-03-19
  It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
• Class IIOngoing2025-03-05
  Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
• Class IIOngoing2025-03-03
  There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
• Class IOngoing2025-02-24
  Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
• Class IOngoing2025-02-21
  Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
• Class IIOngoing2025-02-19
  There is a potential for the sterility of the device to be compromised.
• Class IIOngoing2025-02-13
  Potential breach in pouch packaging which could lead to loss of sterility.
• Class IIOngoing2025-02-12
  The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
• Class IIOngoing2025-02-11
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2025-02-11
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2025-02-11
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2025-02-06
  Devices may have higher than expected amounts of bacterial endotoxin.
• Class IIOngoing2025-01-09
  Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
• Class IIOngoing2025-01-03
  Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
• Class IOngoing2024-12-31
  The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
• Class IIOngoing2024-12-23
  Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
• Class IOngoing2024-12-16
  Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
• Class IIOngoing2024-11-21
  Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
• Class IIOngoing2024-11-18
  Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
• Class IIOngoing2024-11-18
  Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
• Class IIOngoing2024-11-12
  Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
• Class IIOngoing2024-11-06
  Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification leve
• Class IIOngoing2024-10-25
  Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
• Class IIOngoing2024-10-23
  Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
• Class IIOngoing2024-10-21
  Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
• Class IIOngoing2024-10-16
  The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
• Class IIOngoing2024-10-15
  Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
• Class IIOngoing2024-10-09
  Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
• Class IIOngoing2024-10-04
  Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
• Class IIOngoing2024-09-04
  It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
• Class IIOngoing2024-09-03
  Product has been identified as having holes in the packaging.
• Class IIOngoing2024-08-30
  It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
• Class IIOngoing2024-08-28
  Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
• Class IIOngoing2024-08-28
  CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedure
• Class IIOngoing2024-06-27
  Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
• Class IIOngoing2024-06-18
  A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient
• Class IIOngoing2024-05-07
  Potential for an incomplete seal on the packaging tray.
• Class IIOngoing2024-04-30
  There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
• Class IIOngoing2024-04-22
  It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
• Class IIOngoing2024-04-17
  These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-04-08
  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
• Class IIOngoing2024-03-22
  A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
• Class IIOngoing2024-03-14
  Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
• Class IIOngoing2024-03-12
  Products have a lack of sterility assurance.
• Class IIOngoing2024-03-05
  Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17, Standard Specification for Adult Portable Bed Rails and Related Products and 16 CFR Part 1270, Safety Standard for Adult Portable
• Class IIOngoing2024-03-01
  Trumpet Needle Guide ring can detach when excessive pressure is applied.
• Class IOngoing2024-02-26
  Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
• Class IIOngoing2024-02-26
  The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted these units into inventory
• Class IIOngoing2024-02-23
  Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
• Class IIOngoing2024-01-23
  Product failed sterility testing.
• Class IIOngoing2024-01-04
  Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
• Class IIOngoing2023-12-21
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expir
• Class IIOngoing2023-12-20
  There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
• Class IIOngoing2023-11-29
  Surgical gowns were manufactured with the wrong sleeve.
• Class IOngoing2023-11-15
  Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potentia
• Class IIOngoing2023-11-03
  The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
• Class IIOngoing2023-11-01
  This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
• Class IIOngoing2023-10-19
  Undeclared latex
• Class IOngoing2023-10-16
  The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
• Class IOngoing2023-08-04
  Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
• Class IIOngoing2023-08-03
  4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.
• Class IIOngoing2023-08-03
  Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
• Class IIOngoing2023-07-03
  The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
• Class IIOngoing2023-05-23
  The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
• Class IIOngoing2023-05-18
  Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
• Class IIOngoing2023-05-18
  Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
• Class IIOngoing2023-05-15
  Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
• Class IIOngoing2023-05-12
  The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.
• Class IIOngoing2023-05-03
  Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
• Class IIOngoing2023-04-21
  The kits were damaged by water.
• Class IIOngoing2023-03-28
  The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280) included in the DYNDP3000xxP series is labeled with an expiration date.
• Class IIOngoing2023-03-02
  The CirClamp subassembly found in the kit was the incorrect size.
• Class IIOngoing2022-12-27
  The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
• Class IIOngoing2022-12-23
  The kit contained an expired component.
• Class IIOngoing2022-12-22
  The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
• Class IIOngoing2022-12-07
  The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
• Class IIOngoing2022-11-18
  Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
• Class IIOngoing2022-11-17
  Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
• Class IIOngoing2022-11-17
  Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
• Class IIOngoing2022-09-30
  Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
• Class IIOngoing2022-09-09
  Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the ki
• Class IITerminated2022-09-07
  One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
• Class IITerminated2022-09-01
  Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018
• Class IIOngoing2022-08-03
  Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
• Class IIOngoing2022-06-29
  stability failure
• Class IIOngoing2022-05-11
  Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
• Class IIOngoing2022-04-21
  Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
• Class IITerminated2022-03-09
  The mask cuff may disconnect from the device's breathing tube.
• Class IITerminated2022-03-08
  Product was improperly store which may cause a delay in results.
• Class IITerminated2022-03-08
  The product was stored incorrectly due to improper storage controls which may lead to delayed results.
• Class IITerminated2022-03-04
  Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.
• Class IITerminated2022-01-25
  The product was incorrectly shipped at room temperature rather than refrigerated.
• Class IIOngoing2021-12-29
  Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
• Class IIOngoing2021-12-15
  The product contains natural rubber latex but the label states that it does not.
• Class IITerminated2021-12-01
  Product stored incorrectly in temperature controlled setting instead of refrigeration.
• Class IITerminated2021-12-01
  Product stored incorrectly in temperature controlled setting instead of refrigeration.
• Class IITerminated2021-12-01
  Product stored incorrectly in temperature controlled setting instead of refrigeration.
• Class IITerminated2021-11-30
  Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
• Class IITerminated2021-10-27
  NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
• Class IITerminated2021-10-22
  Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be exp
• Class IITerminated2021-08-06
  Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
• Class IITerminated2021-07-01
  The kits may contain an expired component.
• Class IITerminated2021-05-25
  Potential for mold contamination (Aspergillus vadensis)
• Class IIOngoing2021-04-30
  The devices may not meet the minimum required sterility assurance level.
• Class IIOngoing2021-03-15
  Possible false negative or false positive results due to the product being compromised during shipment.
• Class IITerminated2021-01-25
  Product was compromised during shipment.
• Class IIITerminated2021-01-15
  Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
• Class IITerminated2020-11-13
  The cylindrical sponge component is not x-ray detectable.
• Class IITerminated2020-11-05
  RevMedX Trauma Dressing is being recalled due to package seal integrity.
• Class IITerminated2020-10-01
  Product compromised during shipment.
• Class IIOngoing2020-09-15
  The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
• Class IITerminated2020-09-14
  Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
• Class IITerminated2020-09-01
  There have been reports of the suction catheter coming apart from the device assembly during use.
• Class IITerminated2020-08-12
  Potential of incomplete seals impacting the sterility of the kit.
• Class IITerminated2020-07-28
  Product was shipped with refrigeration (ice) instead of frozen (dry ice).
• Class IITerminated2020-07-09
  Potential risk of brush detachment during cleaning.
• Class IIOngoing2020-06-30
  There are reports of the suction catheter coming apart from the device assembly during use.
• Class IITerminated2020-03-09
  Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
• Class IITerminated2020-02-10
  Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
• Class IITerminated2020-01-21
  The sterile pack inside the Complete Delivery System (CDS) did not go through a complete sterilization cycle, therefore the sterility of these components cannot be guaranteed.
• Class IITerminated2020-01-07
  There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.
• Class IIOngoing2019-10-30
  The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end of the circuit.
• Class IITerminated2019-09-18
  Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips.
• Class IIOngoing2019-09-06
  The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.
• Class IIOngoing2019-08-09
  Samples in the identified lot were found to have incomplete or open packaging seals.
• Class IITerminated2019-05-28
  Loose silicone particulate was found to be present on the shaft of the silicone catheters.
• Class ITerminated2019-05-10
  This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment which directly impacts amount of occlusion force necessary to fully seal the tube. This defe
• Class ITerminated2019-05-03
  The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing
• Class IITerminated2019-04-25
  Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
• Class IIOngoing2019-01-31
  Potential for the Semi-Rigid canister lid to fragment during use.
• Class IITerminated2018-08-30
  Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.
• Class IITerminated2018-06-15
  There is potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
• Class IITerminated2018-04-24
  The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
• Class IITerminated2018-02-01
  Packaged with an incorrect overwrap.
• Class IITerminated2017-10-23
  Possible open seal on top portion of the package. Could cause breach of sterility.
• Class IITerminated2017-10-10
  Products labeled as sterile were distributed prior to sterilization
• Class IITerminated2017-08-10
  The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
• Class IITerminated2017-07-18
  Product did not undergo correct sterilization procedures and may potentially be non-sterile.
• Class IITerminated2016-12-14
  Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

Related

• All facilities operated by Medline Industries, LP
• CENTURION MEDICAL PRODUCTS, LP (MI)
• CENTURION MEDICAL PRODUCTS, LP (MI)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →