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

BD PhaSeal Closed System Drug Transfer Devices Missing U.S. Instructions

BD PhaSeal closed system drug transfer devices sold in the U.S. lacked required instructions for use. Proper guidance is critical for safe operation and protecting healthcare workers from hazardous drug exposure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a risk-of-harm product. Missing instructions for use on a closed system drug transfer device designed to prevent occupational exposure to hazardous drugs represents a potential safety risk if devices are used improperly without proper guidance.

Plain-English summary

BD PhaSeal is a closed system drug transfer device used in healthcare settings to contain and reduce occupational exposure to hazardous drugs. The recalled devices include multiple models and configurations shipped to healthcare facilities across the U.S., with over 3.8 million units distributed nationwide.

The devices were shipped to the U.S. market without a U.S. version of the instructions for use. Healthcare professionals relying on device instructions to ensure proper use and safety may encounter difficulties if they need to reference the guidance. Proper instructions are essential for correct operation of the closed system and maintaining the safety protocols designed to protect workers handling hazardous drugs.

Affected healthcare facilities should verify they have the correct U.S. instructions for all BD PhaSeal device models in use. If instructions are unavailable, users should contact BD directly before continuing use of the devices.

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 — Closed System Drug Transfer Device
Hazard
  • missing-instructions
  • improper-use

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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