RegWardenFDA facility compliance records
Facility

Covidien

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

Activity by year

FDA actions on record by year2012: 4 recalls; 2013: 6 recalls; 2014: 3 recalls; 2015: 11 recalls; 2016: 9 recalls; 2017: 11 recalls; 2018: 12 recalls; 2019: 6 recalls; 2020: 9 recalls, 1 inspections; 2021: 14 recalls; 2022: 8 recalls; 2023: 16 recalls; 2024: 12 recalls, 1 inspections; 2025: 4 recalls; 2026: 7 recalls4’126’133’1411’159’1611’1712’186’1910’2014’218’2216’2313’244’257’26
  • Recalls (132)
  • Inspections (2)

Devices registered here (2)

Recalls & enforcement

20267 records
  • Class IIOngoing2026-06-24
    Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
  • Class IIOngoing2026-05-13
    The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
  • Class IIOngoing2026-04-23
    Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
  • Class IIOngoing2026-04-23
    Temperature probe devices lack FDA clearance.
  • Class IIOngoing2026-04-15
    Due to customer complaint regarding incorrect display box labeling.
  • Class IIOngoing2026-04-15
    The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
  • Class IIOngoing2026-01-30
    Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
20254 records
  • Class IIOngoing2025-09-25
    A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
  • Class IIOngoing2025-06-23
    Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm…
  • Class IOngoing2025-05-21
    Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during …
  • Class IOngoing2025-02-26
    Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/…
202412 records
  • Class IIOngoing2024-09-19
    Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
  • Class IIOngoing2024-07-09
    IFU update to address device's battery handling information.
  • Class IOngoing2024-07-09
    Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
  • Class IOngoing2024-06-24
    Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to…
  • Class IIOngoing2024-04-25
    Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
  • Class IIOngoing2024-04-15
    Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
  • Class IIOngoing2024-03-15
    Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
  • Class IIOngoing2024-02-28
    The potential for trocar seal disengagement when using mesh products incorrectly with the device.
  • Class IIOngoing2024-02-21
    Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infe…
  • Class IIOngoing2024-02-14
    Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can…
  • Class IIOngoing2024-01-25
    One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, …
  • Class IIOngoing2024-01-09
    manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
202316 records
  • Class IIOngoing2023-12-21
    Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
  • Class IIOngoing2023-11-16
    Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
  • Class IIOngoing2023-11-16
    Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
  • Class IOngoing2023-09-28
    Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
  • Class IIOngoing2023-08-22
    Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.
  • Class IIOngoing2023-08-22
    Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
  • Class IIOngoing2023-08-10
    Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
  • Class IOngoing2023-06-28
    Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter …
  • Class IIOngoing2023-06-02
    Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primar…
  • Class IIOngoing2023-05-22
    Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.
  • Class IOngoing2023-03-24
    A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dysp…
  • Class IIOngoing2023-03-22
    There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
  • Class IIOngoing2023-03-01
    Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
  • Class IIOngoing2023-02-10
    Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
  • Class IIOngoing2023-01-25
    Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified in…
  • Class IIOngoing2023-01-11
    Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant
20228 records
  • Class IOngoing2022-12-07
    There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
  • Class IIOngoing2022-12-02
    Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
  • Class IIOngoing2022-11-23
    The product is labeled with the incorrect expiration date.
  • Class IIOngoing2022-09-28
    Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintende…
  • Class IIOngoing2022-08-19
    Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
  • Class IOngoing2022-06-08
    There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
  • Class IIOngoing2022-06-07
    Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
  • Class IIOngoing2022-05-13
    The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
202114 records
  • Class IIOngoing2021-12-22
    Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable disconnect and reconnect may cause the monitor to discontinue m…
  • Class IIOngoing2021-12-17
    The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the cat…
  • Class IITerminated2021-12-06
    Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alte…
  • Class IIOngoing2021-11-12
    Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
  • Class ITerminated2021-11-04
    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
  • Class IITerminated2021-09-29
    The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator…
  • Class IITerminated2021-06-23
    Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
  • Class IIOngoing2021-05-28
    This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
  • Class IIOngoing2021-04-29
    The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
  • Class IITerminated2021-03-23
    Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result …
  • Class IIOngoing2021-03-05
    Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the part…
  • Class IITerminated2021-03-04
    Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples …
  • Class IIOngoing2021-02-26
    The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen satur…
  • Class IITerminated2021-01-13
    incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use. Use of an opposite side mesh can result in implant failure and hernia recurrence
20209 records
  • Class IICompleted2020-11-23
    May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complica…
  • Class IIOngoing2020-11-16
    The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
  • Class IIOngoing2020-10-16
    In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,
  • Class IIOngoing2020-08-12
    The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
  • Class IIOngoing2020-06-26
    This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, b…
  • Class IIOngoing2020-05-12
    The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.
  • Class IITerminated2020-04-30
    Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
  • Class IITerminated2020-02-10
    Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
  • Class IITerminated2020-01-17
    Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
20196 records
  • Class IITerminated2019-12-18
    There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
  • Class IIOngoing2019-05-17
    The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
  • Class IITerminated2019-04-29
    The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
  • Class IITerminated2019-03-13
    Sterilization method used was not consistent with the labeling and the approved sterilization method
  • Class IITerminated2019-02-15
    The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
  • Class IITerminated2019-02-15
    Potential for the sterile packaging to be compromised
201812 records
  • Class IIOngoing2018-11-15
    The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
  • Class IITerminated2018-11-05
    The product was released into commercial distribution while subject to importation refusal.
  • Class IITerminated2018-10-31
    This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the pote…
  • Class IITerminated2018-10-05
    The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring addi…
  • Class ITerminated2018-09-18
    Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
  • Class IITerminated2018-08-17
    The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anas…
  • Class IITerminated2018-08-01
    Potential for product sterility breach due to a compromised or pinched seal defect
  • Class IIOngoing2018-07-26
    Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
  • Class IITerminated2018-07-11
    The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
  • Class IITerminated2018-06-15
    Potential proplylene glycol contamination
  • Class IITerminated2018-04-09
    There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
  • Class IITerminated2018-03-15
    Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
201711 records
  • Class IITerminated2017-12-13
    Product reportedly shutting down during use.
  • Class IITerminated2017-11-21
    Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
  • Class IITerminated2017-10-12
    This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate" detection console due to a manufacturing error.
  • Class IITerminated2017-09-21
    Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
  • Class IITerminated2017-09-15
    The device cartridge disengaged during use due to manufacturing error.
  • Class IITerminated2017-09-13
    Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
  • Class IIOngoing2017-08-07
    The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
  • Class IITerminated2017-07-17
    Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
  • Class IITerminated2017-05-09
    Cotton tip of the device may disengage due to insufficient adhesive
  • Class IITerminated2017-03-03
    Product sterility is compromised due to breach of sterile barrier
  • Class IITerminated2017-01-23
    Sterility compromised due to breach in sterile barrier
20169 records
  • Class IITerminated2016-12-16
    Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
  • Class IITerminated2016-10-14
    Sterility of the outer surface of the container compromised due to packaging defect.
  • Class IITerminated2016-09-29
    Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
  • Class IITerminated2016-06-06
    Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.
  • Class IITerminated2016-04-15
    Potential of an allergic reaction in a patient with nickel sensitivity.
  • Class IITerminated2016-03-03
    Compromised sterility due to breach of barrier
  • Class IITerminated2016-01-22
    Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria
  • Class IITerminated2016-01-21
    8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
  • Class IITerminated2016-01-15
    Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (…
201511 records
  • Class IITerminated2015-10-14
    Incorrectly packaged with a 90 degree bend at the distal tip
  • Class IITerminated2015-08-19
    Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
  • Class IITerminated2015-08-06
    Sterility may be compromised
  • Class IITerminated2015-07-31
    Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
  • Class ITerminated2015-07-16
    Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
  • Class IITerminated2015-06-29
    Potential missing segments on the display that can result in misinterpretation of data.
  • Class ITerminated2015-05-08
    Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
  • Class IITerminated2015-04-28
    Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
  • Class IITerminated2015-04-23
    Catheters may not meet antimicrobial specification
  • Class IITerminated2015-04-16
    Devon Light Gloves contain splits or holes compromising the sterility
  • Class IITerminated2015-01-12
    Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
20143 records
  • Class ITerminated2014-12-10
    A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port incorrectly labeled as proximal, and, the proximal balloon port incorrectly labele…
  • Class ITerminated2014-09-18
    Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
  • Class IITerminated2014-05-08
    Straps may separate from the foam pad.
20136 records
  • Class ITerminated2013-12-16
    Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.
  • Class IITerminated2013-08-16
    Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin
  • Class IITerminated2013-05-06
    Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
  • Class IIITerminated2013-04-12
    On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.
  • Class IITerminated2013-04-08
    Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
  • Class IITerminated2013-02-11
    Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
20124 records
  • Class IITerminated2012-08-21
    Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
  • Class IITerminated2012-08-03
    Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.
  • Class IITerminated2012-05-09
    Potential for the sterility barrier to be compromised.
  • Class IITerminated2012-02-09
    Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.

FDA inspections (2)

  • NAI2024-11-21
    No Action Indicated · Compliance: Devices
  • NAI2020-02-28
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Covidien (FEI 1219930) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1219930-covidien/

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