BD PhaSeal Injector Luer — Class II medical device recall Z-2453-2025
Ongoing recall by BD SWITZERLAND SARL, reported 2025-09-03, distributed nationwide. Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions
| Recall number | Z-2453-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BD SWITZERLAND SARL, Eysins, Switzerland |
| Recall initiated | 2025-06-16 |
| Classified | 2025-08-27 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 3,884,670 |
| UPC / GTIN / UDI-DI | 00382905150012, 00382905150036, 00382905150043, 00382905150050, 00382905150524, 00382905150531, 00382905150562, 00382905150579, 00382905150609, 00382905150623, 00382905150630, 00382905150647, 00382905150654, 00382905150708, 00382905150784, 00382905150791, 00382905151002, 00382905151026, 00382905151033, 00382905151040, 00382905151057, 00382905151064, 00382905151071, 00382905151170, 00382905152009 and 7 more |
| Lot numbers | 515001/00382905150012, 515062/00382905150623, 515307/00382905153075 |
| Model numbers | 515001BD, 515003BD, 515004BD, 515005BD, 515052BD, 515053BD, 515056BD, 515057BD, 515060BD, 515062BD, 515063BD, 515064BD, 515065BD, 515070BD, 515079, 515100BD, 515102BD, 515103BD, 515104BD, 515105BD, 515106BD, 515107BD, 515117BD, 515200BD, 515202BD and 6 more |
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: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF: 515105 BD PhaSeal Protector (P50 Multi), REF: 515106 BD PhaSeal Protector (P53), REF: 515107 BD PhaSeal Protector (P55), REF: 515117 BD PhaSeal Connector Luer Lock (C35), REF: 515200 BD PhaSeal Connector Luer Lock (C45), REF: 515202 BD PhaSeal Y-site Connector (C80), REF: 515304 BD PhaSeal L Connector (C90), REF: 515305 BD PhaSeal Infusion Adapter (C100), REF: 515306 BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307 BD PhaSeal Cap for Injector (M50), REF: 515404 BD PhaSeal Connector Cap (M70), REF: 515406 BD PhaSeal Optima Injector (N35-O), REF: 515052 BD PhaSeal Optima Injector (N35-O Multi), REF: 515053 BD PhaSeal Injector Locking (N40-O), REF: 515056 BD PhaSeal Injector Locking (N40-O Multi), REF: 515057 BD PhaSeal Optima Protector (P13-O), REF: 515060 BD PhaSeal Optima Protector (P13-O Multi), REF: 515062 BD PhaSeal Optima Protector (P28-O), REF: 515063 BD PhaSeal Optima Protector (P20-O), REF: 515064 BD PhaSeal Optima Protector (P20-O Multi), REF: 515065 BD PhaSeal Optima Connector (C35-O), REF: 515070 BD PhaSeal Optima Infusion Adapter (C100-O), 515078 BD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2453-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.