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Becton Dickinson GmbH

Germany DE-MF-000018170 Last updated 22 Oct 2026

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Devices
12
Registries
EUDAMEDFDA
FDA recalls
499113 ongoing

Catalogue12

  • Phoenix Ref 449474

    Class B EUDAMED Active

  • Bbl Ref 257481

    Class B EUDAMED Active

  • Bbl Ref 257663

    Class B EUDAMED Active

  • Phoenix Ref 448651

    Class B EUDAMED Active

  • Bbl Ref 254106

    Class B EUDAMED Active

  • Bbl Ref 257585

    Class C EUDAMED Active

  • Isovitalex Ref 254060

    Class A EUDAMED Active

  • Trypticase Ref 254053

    Class A EUDAMED Active

  • Trypticase Ref 254086

    Class A EUDAMED Active

  • Isovitalex Ref 254089

    Class A EUDAMED Active

  • Pseudosel Ref 254419

    Class B EUDAMED Active

  • Trypticase Ref 254051

    Class A EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • IVDR 805735 Supplemented

    Quality management system EU IVDR

    Issued
    14 Nov 2025
    Expires
    8 Jun 2027
    Reason
    Change approved

Related companies

Notified bodies

  • Notified body 2797

FDA recalls499

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 499 recalls.

  • 2026

    • 13 Aug 2026 Z-0139-2027 Not yet classified Ongoing Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
    • 13 Aug 2026 Z-0140-2027 Not yet classified Ongoing Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
    • 27 Apr 2026 Z-2248-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2249-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2250-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2251-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2252-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2253-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2254-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2255-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
Show the 25 most recent of 499 recalls

  • 2026

    • 27 Apr 2026 Z-2256-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 27 Apr 2026 Z-2257-2026 Class I Ongoing This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
    • 7 Apr 2026 Z-1982-2026 Class II Ongoing BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
    • 7 Apr 2026 Z-1983-2026 Class II Ongoing BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
    • 27 Jan 2026 Z-1496-2026 Class II Ongoing During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

  • 2025

    • 23 Oct 2025 Z-0484-2026 Class II Ongoing The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
    • 14 Oct 2025 Z-0504-2026 Class II Ongoing BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
    • 23 Sep 2025 Z-0235-2026 Class II Ongoing Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
    • 23 Sep 2025 Z-0236-2026 Class II Ongoing Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
    • 23 Sep 2025 Z-0237-2026 Class II Ongoing Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
    • 23 Sep 2025 Z-0238-2026 Class II Ongoing Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
    • 23 Sep 2025 Z-0239-2026 Class II Ongoing Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
    • 23 Sep 2025 Z-0240-2026 Class II Ongoing Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
    • 23 Jun 2025 Z-2162-2025 Class II Ongoing Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
    • 20 May 2025 Z-2023-2025 Class II Ongoing BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.

Information

Country
Germany
Address
8-12, Tullastrasse, Heidelberg, Germany
Website
www.bd.com/en-eu/ This address returned "not found" when we last checked — the site may have moved.Last checked 18 Oct 2026.
PRRC contact
Megan Reeher
EUDAMED SRN
DE-MF-000018170
FDA FEI number
1000366600