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BD SWITZERLAND SARL

Switzerland Last updated 25 Oct 2026

Devices
172
Registries
EUDAMEDFDA
FDA recalls
1512 ongoing

Catalogue172

Page 4 of 4

  • BD MaxZero™ Ref MZ9283

    Class IIa EUDAMED Active

  • BD MaxZero™ Ref MZ1000

    Class IIa EUDAMED Active

  • BD SmartSite™ Ref 20059E-0006

    Class IIa EUDAMED Active

  • Alaris Ref 80300UNS01-72

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS02-72

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS02-70

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS01-34

    Class IIb EUDAMED Active

  • Alaris Ref 80223UNS02-53

    Class IIb EUDAMED Active

  • Alaris Ref 80223UNS02-30

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS02-33

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS01-73

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS02-92

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS01-74

    Class IIb EUDAMED Active

  • Alaris Ref 80223UNS02-33

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS01-50

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS02-34

    Class IIb EUDAMED Active

  • Alaris Ref 80223UNS02-72

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS01-235

    Class IIb EUDAMED Active

  • Alaris Ref 80223UNS02-74

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS01-33

    Class IIb EUDAMED Active

  • Alaris Ref 80223UNS02-50

    Class IIb EUDAMED Active

  • Alaris Ref 80300UNS02-74

    Class IIb EUDAMED Active

Showing 151-172 of 172

EUDAMED certificates1

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • MDR 745680 Supplemented

    Quality management system EU MDR

    Issued
    27 Jul 2026
    Expires
    3 Sep 2028
    Reason
    Change approved

Related companies

Notified bodies

  • Notified body 2797

FDA recalls15

Device pages show only the recalls that name the device or its 510(k)/PMA.

Showing the 10 most recent of 15 recalls.

  • 2026

    • 19 Aug 2026 Z-3080-2026 Class I Ongoing Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
    • 16 Jun 2026 Z-2941-2026 Class II Ongoing Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
    • 4 Jun 2026 Z-2654-2026 Class II Ongoing Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
    • 21 May 2026 Z-2514-2026 Class II Ongoing Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

  • 2025

    • 16 Jun 2025 Z-2453-2025 Class II Ongoing Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
    • 12 May 2025 Z-1970-2025 Class II Ongoing Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
    • 12 May 2025 Z-1971-2025 Class II Ongoing Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
    • 12 May 2025 Z-1972-2025 Class II Ongoing Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
    • 12 May 2025 Z-1973-2025 Class II Ongoing Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
    • 12 May 2025 Z-1974-2025 Class II Ongoing Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Show all 15 recalls

  • 2025

    • 20 Feb 2025 Z-1509-2025 Class II Ongoing Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

  • 2024

    • 18 Apr 2024 Z-1944-2024 Class II Ongoing Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.

  • 2020

    • 9 Apr 2020 Z-1967-2020 Class II Terminated The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
    • 9 Apr 2020 Z-1968-2020 Class II Terminated The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
    • 9 Apr 2020 Z-1969-2020 Class II Terminated The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

Frequently asked questions

How many devices does BD SWITZERLAND SARL have in the registry?

The registry currently lists 172 devices for BD SWITZERLAND SARL. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for BD SWITZERLAND SARL?

FDA recall records list 15 recalls initiated by BD SWITZERLAND SARL, the most recent initiated on 2026-08-19. 12 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.

What EUDAMED certificates are recorded for BD SWITZERLAND SARL?

EUDAMED lists 1 certificate for BD SWITZERLAND SARL (quality management system) under MDR. The most recent was issued on 2026-07-27.

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

Information

Address
17, Route de Crassier, Eysins, Switzerland
Website
www.bd.com
Phone
+41 21 556 30 00
PRRC contact
Michael Campbell
EUDAMED SRN
CH-MF-000026539
FDA FEI number
3012798826