Medline recalls convenience kits containing specific 10mL polycarbonate syringes due to unapproved design changes outside 510(k) clearance. Affected kits include ANGIO KIT PACK DYNJ50783B and others with listed serial numbers.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that include certain 10mL polycarbonate colored syringes because they have unapproved design changes not cleared by the FDA. This could lead to safety issues if used without proper regulatory approval.
The syringes were made with design changes that the FDA did not approve through the 510(k) clearance process. This means they might not meet safety standards for medical use, potentially causing harm if used improperly.
Healthcare professionals and medical facilities that own or use the recalled Medline Convenience Kits with specific syringe models and serial numbers listed in the recall notice.
Check for the product names and model numbers listed in the recall, such as ANGIO KIT PACK DYNJ50783B, along with the specific serial numbers (UDI-DI codes and lots) provided in the notice.
Identify if your Medline Convenience Kit includes any of the listed syringe models and serial numbers in the recall notice.
The recall is due to unapproved design changes to the syringes outside of the 510(k) clearance process, which may not meet FDA safety standards.
The affected products include Medline Convenience Kits with specific syringe models like ANGIO KIT PACK DYNJ50783B and others with the listed serial numbers and lots.
The recall does not specify a stop-use instruction; you should check if your kit contains affected items before taking action.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1884-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1884-2026 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.
