The Recall Desk
ModerateFDA (Devices)·Z-2453-2025·Announced 2025-09-03

Drug transfer devices recalled for shipping without US instructions for use

BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is a missing US instructions-for-use document rather than any defect in the devices.

Plain-English summary

BD PhaSeal closed system drug transfer devices are being recalled across a wide range of references, including Injector Luer (N30C) REF 515001, Injector Luer Lock (N35) REF 515003, Injector Luer Lock (N35C) REF 515004, several Protector references from 515100 to 515117, and Connector references including 515200, 515202, 515304 and 515305. Affected lot numbers and expiry dates are listed in the recall notice. The recall covers 3,884,670 units distributed nationwide in the United States.

The devices were shipped to the US market without a US version of the instructions for use, which the manufacturer states could be an issue if a healthcare professional is prompted to review it. The FDA classified the action as Class II. The notice does not describe a defect in the devices themselves.

Pharmacies and healthcare facilities should follow the manufacturer's instructions for obtaining the correct instructions for use.

The recalled product

Product
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
Manufacturer
BD SWITZERLAND SARL
Category
Medical Device — Drug Transfer System
Hazard
  • missing-instructions
  • documentation-error
  • class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 2403002(31-Aug-26)
  • 2403003(31-Aug-26)
  • 2404006(30-Sep-26)
  • 2405007(31-Oct-26)
  • 2405014(31-Oct-26)
  • 2408005(31-Jan-27)
  • 2408006(31-Jan-27)
  • 2409005(28-Feb-27)
  • 2403713(31-Aug-26)
  • 2404001(30-Sep-26)
  • 2404002(30-Sep-26)
  • 2404003(30-Sep-26)
  • 2404004(30-Sep-26)
  • 2404005(30-Sep-26)
  • 2410001(31-Mar-27)
  • 2410002(31-Mar-27)
  • 2411001(30-Apr-27)
  • 2411002(30-Apr-27)
  • 2411003(30-Apr-27)
  • 2411709(30-Apr-27)

Distribution

Distributed nationwide across the United States.

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