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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 1,001-1,050 of 1,143

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  • Softima® Ref 42735E

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 044015RU

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4621716J

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4611380U

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  • Flexima® Ref 044025F

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  • Flexima® Active Ref 4642725L

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  • Flexima® Active Ref 4622380P

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  • Softima® Active Ref 4620215A

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  • Flexima® Active Ref 4610135P

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  • Flexima® Ref 44037T

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 44220J

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  • Ally® Belt Ref 5032AT

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  • Flexima® Active Ref 4641715X1

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  • Flexima® Ref 044015FR

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  • Softima® Ref 44225CH

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  • Softima® Active Ref 4620215AT

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  • Flexima® Ref 044040L

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  • Flexima® Active Ref 4610140T

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  • Flexima® Active Ref 4620130J

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  • Flexima® Active Ref 4612115T

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  • Flexima® Ref 044170J

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  • Flexima® Ref 044914FR

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Urimed® Vision Ref IH4536A

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4612215K

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  • Flexima® Active Ref 4621716F

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  • Flexima® Ref 42715X1

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Key Ref 62050FR

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4642730K

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  • Softima® Active Ref 4621215K

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  • Softima® Ref 44118E

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4620115

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  • Softima® Active Ref 4622715DE

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  • Flexima® Active Ref 4620380

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  • Softima® Active Ref 4642715K

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  • Softima® Active Ref 4621215DE

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  • Flexima® Active Ref 4641715U

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  • Flexima® Ref 044025A

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  • Softima® Active Ref 4622215K

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  • Flexima® Active Ref 4622115

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Active Ref 4611380F

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Ref 044914E

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 044025J

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4620140K

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4611380A

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Key Ref 62364M

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Active Ref 4622716CH

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Softima® Ref 42716K

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 42715J

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 44225M

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Flexima® Ref 044914N

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1,001-1,050 of 1,143

Showing 1,001-1,050 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.