Medline recalls convenience kits containing specific 10mL polycarbonate syringes with unapproved design changes that may not meet FDA safety standards.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that include certain 10mL polycarbonate colored syringes due to unapproved design changes. These changes could mean the products don't meet FDA safety requirements, though the recall doesn't specify immediate risks to users.
The products have unapproved design changes outside of FDA 510(k) clearance, which means they might not meet safety standards. However, the recall does not describe any specific hazards like injuries or failures in normal use.
Healthcare professionals and medical facilities that own or use the recalled Medline Convenience Kits with specific syringe models. Patients using these syringes are unlikely to be affected directly.
Check for Medline Convenience Kits with syringes labeled as JUDKINS PACK DYNJ51126 ANGIO, DYNJ32555C, DYNJ66631, DYNJ46153B, DYNJ26855F, DYNJ24530I, DYNJ0220880V, DYNJ30077D, DYNJ0545064X, DYNJ39057C, DYNJ61015B, or DYNJ47710C. Look for the specific lot numbers listed in the recall notice.
Look for the specific syringe model codes and lot numbers listed in the recall notice to confirm if your kit is affected.
The products have unapproved design changes outside of FDA 510(k) clearance, which may not meet safety standards.
The recall does not specify immediate risks or hazards, so there is no urgent need to stop using them.
The recall does not provide a remedy, so there is no action required beyond checking if your products are affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1876-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1876-2026 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.
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