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B. BRAUN MEDICAL SAS

France FR-MF-000000674 Last updated 21 Oct 2026

Devices
1,143
Registries
EUDAMEDFDA
FDA recalls
510225 ongoing

Catalogue1,143

Page 1 of 23

Showing 1-50 of 1,143

FDA recalls510

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 510 recalls.

  • 2026

    • 14 Sep 2026 Z-0193-2027 Not yet classified Ongoing Potential for leakage and backflow at the Safsite valve.via FDA establishment B. BRAUN MEDICAL INC.
    • 4 Aug 2026 Z-3089-2026 Class II Ongoing Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.via FDA establishment B. BRAUN MEDICAL INC.
    • 6 May 2026 Z-2276-2026 Class I Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 6 May 2026 Z-2277-2026 Class I Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 6 May 2026 Z-2278-2026 Class I Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 19 Mar 2026 Z-1798-2026 Class I Ongoing Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.via FDA establishment B. BRAUN MEDICAL INC.
    • 19 Mar 2026 Z-1799-2026 Class I Ongoing Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.via FDA establishment B. BRAUN MEDICAL INC.
    • 19 Mar 2026 Z-1800-2026 Class I Ongoing Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.via FDA establishment B. BRAUN MEDICAL INC.
    • 19 Mar 2026 Z-1801-2026 Class I Ongoing Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.via FDA establishment B. BRAUN MEDICAL INC.
    • 19 Mar 2026 Z-1802-2026 Class I Ongoing Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.via FDA establishment B. BRAUN MEDICAL INC.
Show the 25 most recent of 510 recalls

  • 2026

    • 19 Mar 2026 Z-1803-2026 Class I Ongoing Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.via FDA establishment B. BRAUN MEDICAL INC.
    • 2 Feb 2026 Z-1481-2026 Class II Ongoing The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.via FDA establishment B. BRAUN MEDICAL INC.
    • 2 Feb 2026 Z-1482-2026 Class II Ongoing The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.via FDA establishment B. BRAUN MEDICAL INC.
    • 2 Feb 2026 Z-1483-2026 Class II Ongoing The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2263-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2264-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2265-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2266-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2267-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2268-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2269-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Jan 2026 Z-2270-2026 Class II Ongoing 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.via FDA establishment B. BRAUN MEDICAL INC.

  • 2025

    • 29 Oct 2025 Z-0603-2026 Class II Ongoing Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Oct 2025 Z-0604-2026 Class II Ongoing Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).via FDA establishment B. BRAUN MEDICAL INC.
    • 29 Oct 2025 Z-0605-2026 Class II Ongoing Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).via FDA establishment B. BRAUN MEDICAL INC.

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • B. Braun Medical Inc. BETHLEHEM, PA · US FEI 2521402
  • B. Braun Medical, Ltd. GYONGYOS Heves · HU FEI 3007655970

About

B. Braun offers medical devices and healthcare solutions for a wide range of areas.

Translated from the manufacturer's own website. Source

Information

Country
France
Address
26, RUE ARMENGAUD, SAINT-CLOUD, France
Website
www.bbraun.fr
PRRC contact
Emmanuel Da Silva
EUDAMED SRN
FR-MF-000000674