BD SWITZERLAND SARL

• Alaris Ref 80300UNS02-32

  Class IIb EUDAMED Active

• BD SmartSite™ Ref 37262E

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9276

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5309

  Class IIa EUDAMED Active

• Bodycomm Ref BODYCOMMSW-4.0

  Class IIb EUDAMED Active

• Phaseal Ref 515076

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5303

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9303

  Class IIa EUDAMED Active

• Phaseal Ref 515005

  Class IIa EUDAMED Active

• Alaris Ref 1000SP02442

  Class IIb EUDAMED Active

• BD MaxPlus™ Ref MP9027C-0006

  Class IIa EUDAMED Active

• Connecta Ref 394501

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9295

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZXT5304

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZX5305

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9321

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9313

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZXT5303

  Class IIa EUDAMED Active

• Alaris Ref 80223UNS02-73

  Class IIb EUDAMED Active

• Alaris Ref 80223UNS02-035

  Class IIb EUDAMED Active

• BD SmartSite™ Ref 2309E-0006

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9294

  Class IIa EUDAMED Active

• Connecta Ref 394926

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 20041E-0006

  Class IIa EUDAMED Active

• Alaris Ref 80223UNS02-34

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZXT9001

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5306

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-70

  Class IIb EUDAMED Active

• Phaseal Ref 515067

  Class IIa EUDAMED Active

• Phaseal Optima Ref 515053

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9324

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS02-54

  Class IIb EUDAMED Active

• Phaseal Ref 515303

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 20049E7D

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9290

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5312

  Class IIa EUDAMED Active

• Connecta Ref 394961

  Class IIa EUDAMED Active

• Connecta Ref 395095

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS02-52

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZ9278

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-32

  Class IIb EUDAMED Active

• Texium Ref MY8005-0006

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 2202E-0006

  Class IIa EUDAMED Active

• Alaris Ref 80223UNS02-54

  Class IIb EUDAMED Active

• Alaris Ref 80300UNS02-73

  Class IIb EUDAMED Active

• Connecta Ref 395061

  Class IIa EUDAMED Active

• Texium Ref 10012241

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5301

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-54

  Class IIb EUDAMED Active

• Alaris Ref 80300UNS02-30

  Class IIb EUDAMED Active

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.

Country

Switzerland

Address

17, Route de Crassier, Eysins, Switzerland

Website

www.bd.com

Email

[email protected]

Phone

+41 21 556 30 00

PRRC contact

Michael Campbell

EUDAMED SRN

CH-MF-000026539

FDA FEI number

3012798826