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B. Braun Medical SAS

Active in EUDAMED
Also registered as B. BRAUN MEDICAL

Francefrom SRN EUDAMED FDA SRN FR-MF-000000674

Devices
1,143
Registrations
EUDAMEDFDA
FDA recalls
510225 ongoing

Catalogue1,143

Newest first, rows 401-450 of 1,143

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  • Softima® Ref 044015E

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4612115DE

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4621215FR

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4642715U

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  • Flexima® Ref 42815T

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  • Flexima® Active Ref 4621215V

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  • Proxima® Ref 55410TR

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  • Flexima® Ref 044170FR

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  • Softima® Active Ref 4621215E

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  • Flexima® Ref 44018N

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 42715BR

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  • Softima® Active Ref 4620135CH

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  • Flexima® Active Ref 4612115F

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  • Flexima® Ref 42740A

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  • Flexima® Ref 44117A

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  • Softima® Active Ref 4612215DE

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 44031T

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Key Ref 62040E

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  • Softima® Ref 42971E

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 44917V

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Proxima®+ Ref 54510T

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4610130F

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  • Flexima® Active Ref 4612380N

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  • Softima® Active Ref 4620115A

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  • Softima® Active Ref 4612115E

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  • Flexima® Active Ref 4622115U

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  • Flexima® Ref 044070VN

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  • Softima® Ref 44018K

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Proxima® Ref 56410T

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4620130CH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 44836A

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Ally® Belt Ref 5031J

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 42715F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Ref 62050CH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Proxima® Ref 55410BG

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 44230A

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4612115

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  • Softima® Ref 044035K

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  • Flexima® Active Ref 4622380RO

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  • Flexima® Active Ref 4620125V

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  • Softima® Active Ref 4620125AT

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  • Flexima® Ref 044030L

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Key Ref 62080BG

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 42715P

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  • Flexima® Ref 44919FR

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  • Flexima® Active Ref 4622717L

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  • Flexima® Active Ref 4620215

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 044914M

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4611115D

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Ally® Ref 5028P

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 401-450 of 1,143

Showing 401-450 of 1,143

Company details

EUDAMED SRN
FR-MF-000000674
EU VAT number
FR28562050856
EUDAMED status
Active
EUDAMED registered name
B. BRAUN MEDICAL SAS
EUDAMED abbreviated name
BBM SAS
Registered address
26, RUE ARMENGAUD, 92210, SAINT-CLOUD, France
Website
www.bbraun.fr
PRRC contact
Emmanuel Da Silva(public in EUDAMED)

FDA recalls510

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 11
  • 2018 95
  • 2019 17
  • 2020 3
  • 2021 19
  • 2022 8
  • 2023 17
  • 2024 50
  • 2025 132
  • 2026 22

136 initiated before 2017

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. Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, MN, NJ, NY, OH, PA, TX, WA and the countries of Australia, Germany Malaysia, New Zealand.
      Submission number: K942988
    • 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. Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX,…
      Full distribution text Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, IL, IN, LA, MA, MD, NC, NJ, NY, PA, TN, TX, VA, WA the country of Canada.
      Submission number: K942988
    • 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. Distribution: US Nationwide distribution.
    • 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. Distribution: US Nationwide distribution.
    • 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. Distribution: US Nationwide distribution.
    • 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K080807
    • 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K080807
    • 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K080807
    • 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K080807
    • 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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K080807
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. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Submission number: K080807
    • 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. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
    • 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. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
    • 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. Distribution: Worldwide - US Nationwide distribution in the state of TX and the country of Costa Rica.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
    • 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. Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

  • 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. Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Submission number: K790062
    • 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. Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Submission numbers: K790062, K942988
    • 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. Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Submission number: K954123

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

From the company website

Read 18 Sep 2026

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

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does B. BRAUN MEDICAL SAS have in the registry?

The registry currently lists 1143 devices for B. BRAUN MEDICAL SAS. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for B. BRAUN MEDICAL SAS?

FDA recall records list 510 recalls initiated by B. BRAUN MEDICAL SAS, the most recent initiated on 14 Sep 2026. 225 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

Which FDA establishments are linked to B. BRAUN MEDICAL SAS?

2 FDA establishments are linked to B. BRAUN MEDICAL SAS in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.