RegWardenFDA facility compliance records
Company

B. BRAUN MEDICAL INC.

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

Recalls by year

FDA actions on record by year2012: 2 recalls; 2013: 5 recalls; 2014: 4 recalls; 2015: 2 recalls; 2016: 5 recalls; 2017: 1 recalls; 2018: 3 recalls; 2019: 3 recalls; 2021: 3 recalls; 2022: 3 recalls; 2023: 6 recalls; 2024: 5 recalls; 2025: 5 recalls; 2026: 5 recalls2’125’134’142’155’161’173’183’19’203’213’226’235’245’255’26
  • Recalls (52)

Registered facilities (5)

Recalls & enforcement

20265 records
  • Class IIOngoing2026-08-04
    Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
  • Class IOngoing2026-05-06
    These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
  • Class IOngoing2026-03-19
    Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
  • Class IIOngoing2026-02-02
    The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
  • Class IIOngoing2026-01-29
    B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL® Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
20255 records
  • Class IIOngoing2025-10-29
    Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
  • Class IOngoing2025-09-30
    The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
  • Class IIOngoing2025-09-18
    Potential for the lid of the catheter connector to be in the incorrect position.
  • Class IOngoing2025-07-09
    Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
  • Class IIOngoing2025-02-17
    Increased risk for valve housing detachment causing leakage.
20245 records
  • Class IIOngoing2024-12-04
    Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
  • Class IIOngoing2024-08-15
    Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloodline to the Locksite may result in the potential for occlusion during prograde rinseback procedures. If the patient connector is not fully inserted into the Locksite, the internal se…
  • Class IIOngoing2024-08-08
    Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
  • Class IIOngoing2024-06-17
    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of me…
  • Class IIOngoing2024-01-22
    Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.
20236 records
  • Class IOngoing2023-11-01
    In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in seri…
  • Class IIOngoing2023-09-26
    Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations…
  • Class IOngoing2023-09-21
    Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body funct…
  • Class IIOngoing2023-08-07
    The sterile blister packaging may be damaged, and sterility may be compromised
  • Class IIOngoing2023-07-31
    Product may be mislabeled with an incorrect lid stock label.
  • Class IIOngoing2023-06-05
    Kits were assembled with the incorrect Filter Straw.
20223 records
  • Class IIOngoing2022-09-15
    The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare wo…
  • Class IITerminated2022-01-31
    This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays in treatment due to the need to replace the device or may cause…
  • Class IITerminated2022-01-28
    Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a …
20213 records
  • Class IITerminated2021-08-10
    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
  • Class IITerminated2021-06-25
    There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
  • Class IITerminated2021-03-15
    BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
20193 records
20183 records
  • Class IITerminated2018-07-20
    The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
  • Class IITerminated2018-06-04
    There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.
  • Class IITerminated2018-05-09
    There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
20171 record
  • Class IITerminated2017-06-21
    B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub …
20165 records
  • Class IITerminated2016-07-29
    Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
  • Class IITerminated2016-07-11
    B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specificatio…
  • Class IITerminated2016-04-26
    Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
  • Class IITerminated2016-04-14
    BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing is located.
  • Class ITerminated2016-04-01
    Potential leakage of conductivity sensors of the Dialog Dialysis machines.
20152 records
  • Class IITerminated2015-08-27
    Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.
  • Class IITerminated2015-03-27
    There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contaminati…
20144 records
  • Class IITerminated2014-08-06
    The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.
  • Class IITerminated2014-05-29
    Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.
  • Class IITerminated2014-04-03
    B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
  • Class IITerminated2014-01-08
    Complaints were received reporting leakage on certain lots of SAFSITE® Injection Sites and IV Sets manufactured with SAFSITE® Injection Sites.The SAFSITE® Injection Site is intended to provide needle free access on IV and Extension Sets.
20135 records
  • Class IITerminated2013-12-13
    Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.
  • Class IITerminated2013-09-27
    One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
  • Class IITerminated2013-08-05
    Reports were received of an incorrectly assembled Outlook Safety Infusion System Burette Set (Product Code 375038), and the investigation determined that one of the ULTRASITE injection sites and corresponding low pressure backcheck valve was assembled upside down.
  • Class IITerminated2013-04-04
    Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined that the leakage is the result of a misaligned cannula (needle) on the addEASE…
  • Class IITerminated2013-03-01
    There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).
20122 records
  • Class ITerminated2012-03-23
    Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, f…
  • Class IITerminated2012-03-23
    Firm has become aware of the potential for breakage of the pole clamp locking grids, or rasters, in the Space Pole Clamps.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “B. BRAUN MEDICAL INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9925035-b-braun-medical-inc/

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