Medline recalls convenience kits with unapproved design changes to 10mL polycarbonate syringes that may not meet FDA safety standards.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits containing specific 10mL polycarbonate syringes due to unapproved design changes that could affect safety compliance. This recall affects healthcare professionals and patients using these kits for medical procedures.
The syringes have unapproved design changes outside of FDA 510(k) clearance, meaning they may not meet safety standards. This could lead to potential issues with product performance or safety during medical procedures.
Healthcare professionals and patients who use Medline convenience kits with the recalled syringes are most at risk. The recall applies to specific model numbers and production lots.
Check for the model numbers DYNJ38587A, DYNJ38587B, DYNJ30078D, or DYNJ59108B on the syringes. The recall includes specific production lots listed in the notice.
Look for lot numbers such as 20BBF696, 20EBH917, or 23DBP789 on the syringe packaging.
The products have unapproved design changes outside of FDA 510(k) clearance, which may affect safety compliance.
The affected models include DYNJ38587A, DYNJ38587B, DYNJ30078D, and DYNJ59108B syringes with specific production lots.
The recall does not specify a stop-use instruction; the remedy is null, so users should check the lot numbers and contact Medline if needed.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1879-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1879-2026 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.
