BD recalls several PhaSeal injector luer devices sold in the U.S. due to missing U.S. instructions for healthcare professionals. This could lead to review issues if prompted. Affected products include specific models with reference numbers.
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.
BD is recalling multiple PhaSeal injector luer devices sold in the U.S. because they were shipped without U.S. version instructions for healthcare professionals. This could cause confusion or errors if a healthcare professional needs to review the instructions.
The devices were shipped to the U.S. without updated U.S. instructions for use. If a healthcare professional is prompted to review the instructions, this could lead to confusion or errors in their use.
Healthcare professionals who use these devices in the U.S. are most at risk. The recall affects specific models with reference numbers listed in the notice.
Check for the following model names and reference numbers: BD PhaSeal Injector Luer (N30C), REF: 515001; BD PhaSeal Injector Luer Lock (N35), REF: 515003; and other specific models listed in the recall notice.
Review the model names and reference numbers listed in the recall notice to confirm if your device is affected.
BD shipped these devices to the U.S. without U.S. version instructions for healthcare professionals, which could cause issues if prompted to review them.
The affected models include BD PhaSeal Injector Luer (N30C), REF: 515001; BD PhaSeal Injector Luer Lock (N35), REF: 515003; and other specific models with reference numbers listed in the recall notice.
Yes, check your device's model and reference number against the list provided in the recall notice to see if it's affected.
We’ve drafted a message you can send BD to request your refund or repair — edit it as you like.
Subject: Recall Z-2453-2025 — BD BD Hello, I own a BD that is covered by recall Z-2453-2025 from BD. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
