Medline recalls convenience kits containing unapproved 10mL polycarbonate syringes due to design changes outside FDA clearance. Affected kits include specific model numbers and lots. Consumers should check their kits for listed serial numbers.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that contain certain 10mL polycarbonate syringes because the design changes were not approved by the FDA. This could lead to safety issues if the syringes are used without proper regulatory clearance.
The syringes were modified without going through the FDA's 510(k) clearance process, which means they might not meet safety standards. This could potentially lead to issues like improper function or injury if used in medical settings without proper approval.
Healthcare professionals and medical facilities that use Medline convenience kits with the specific syringe models listed in the recall. Those handling the kits are most at risk if the unapproved design causes improper use.
Check if your Medline Convenience Kit contains the specific syringe models listed: EYE PACK DYNJ35056A or HEART CATH PACK DYNJ69318A. Look for the lot numbers mentioned in the recall, such as 24ABN639 or 23DMD456.
Identify if your Medline Convenience Kit includes the specific syringe models (EYE PACK DYNJ35056A or HEART CATH PACK DYNJ69318A) with the listed lot numbers.
The syringes were modified without going through the FDA's 510(k) clearance process, which means they might not meet safety standards.
Check your Medline Convenience Kit for the specific syringe models and lot numbers listed in the recall. If you have them, you should contact Medline for further instructions.
Yes, the recall includes lot numbers like 24ABN639, 23DMD456, 23EMB847, and others as listed in the record.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1886-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1886-2026 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.
