Medline recalls specific perfusion syringes due to potential sensitization risks from BD Luer Tip Caps failing biocompatibility tests. Affected units include lot 25FMJ081 with UDI/DI numbers 101934896215321533.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
Medline is recalling specific perfusion syringes that contain BD Luer Tip Caps which failed biocompatibility testing. This could potentially cause sensitization, irritation, or other health issues for users, though the risk is not immediate.
The BD Luer Tip Caps in the syringes failed routine biocompatibility testing. This means the caps could cause sensitization, irritation, or other health issues depending on how long and how much they contact the syringe.
Healthcare professionals using Medline perfusion syringes with lot number 25FMJ081 are most at risk. Patients using these syringes may experience sensitization or irritation if the caps fail biocompatibility tests.
Check for lot number 25FMJ081 on the syringe packaging. The UDI/DI numbers are 10193489621532 (each) and 40193489621533 (case).
Look for lot number 25FMJ081 and UDI/DI numbers 10193489621532 (each) or 40193489621533 (case) on the syringe packaging.
The BD Luer Tip Caps in the syringes failed routine biocompatibility testing, which could lead to sensitization, irritation, or other health issues.
Check the lot number and UDI/DI numbers on the packaging. If it matches the recalled items, contact Medline for further instructions.
The recall indicates potential for sensitization or irritation, but not immediate serious injury. The risk is considered low.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0886-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-0886-2026 from Medline. 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.
