BD PhaSeal Injector Luer: Missing U.S. Instructions Could Cause Issues for Healthcare
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.
Lower-risk 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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/52039-bd-phaseal-injector-luer-missing-u-s-instructions-could-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/52039-bd-phaseal-injector-luer-missing-u-s-instructions-could-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2453-2025
Cite this page
“BD PhaSeal Injector Luer: Missing U.S. Instructions Could Cause Issues for Healthcare.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52039-bd-phaseal-injector-luer-missing-u-s-instructions-could-cause. Based on FDA recall #Z-2453-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2453-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
BD- Category
Medical device
What to do — step by step
Check Product Details
Review the model names and reference numbers listed in the recall notice to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 37 states.
FDA distribution: “US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2453-2025 (June 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2453-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.