BD SWITZERLAND SARL

• BD MaxPlus™ Ref MP2002C-0006

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-035

  Class IIb EUDAMED Active

• Alaris Ref 1000SP02407

  Class IIb EUDAMED Active

• Alaris Ref 80223UNS02-52

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZ9281

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5310

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS02-50

  Class IIb EUDAMED Active

• Phaseal Ref 515602

  Class IIa EUDAMED Active

• Alaris Ref 80223UNS02-70

  Class IIb EUDAMED Active

• BD MaxPlus™ Ref MP2005C-0006

  Class IIa EUDAMED Active

• Texium Ref MY8060-0006

  Class IIa EUDAMED Active

• BD Alaris™ Ref 500-002V

  Class IIa EUDAMED Active

• Phaseal Ref 515300

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-30

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZ9277

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-52

  Class IIb EUDAMED Active

• Connecta Ref 394936

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS02-235

  Class IIb EUDAMED Active

• Alaris Ref 80223UNS02-32

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZ9326

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 20159E7D

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 2300E

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 2201-0006

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS02-035

  Class IIb EUDAMED Active

• Texium Ref MY8030-0006

  Class IIa EUDAMED Active

• Alaris Ref 80223UNS02-92

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZ9329

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5304

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS01-53

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZX5302

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 10013365-0006

  Class IIa EUDAMED Active

• Alaris Ref 80300UNS02-53

  Class IIb EUDAMED Active

• BD MaxZero™ Ref MZXT5307

  Class IIa EUDAMED Active

• Connecta Ref 394911

  Class IIa EUDAMED Active

• Connecta Ref 394983

  Class IIa EUDAMED Active

• Texium Ref MY8003-0006

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 500-021EV

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 20060E7D

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ5305

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9288

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9279

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 2205E-0006

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9289

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 30207E

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9293

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZ9300

  Class IIa EUDAMED Active

• BD MaxPlus™ Ref MP2000C-0006

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 2203E-0006

  Class IIa EUDAMED Active

• BD SmartSite™ Ref 2000E7D

  Class IIa EUDAMED Active

• BD MaxZero™ Ref MZX5306

  Class IIa 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.

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