Medline recalls convenience kits containing 10mL polycarbonate syringes with unapproved design changes that may not meet FDA clearance standards.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that include certain 10mL polycarbonate syringes due to unapproved design changes not cleared by the FDA. This could mean the products don't meet safety standards for medical use.
The syringes have design changes that weren't approved by the FDA through the 510(k) clearance process. This means they might not meet the required safety standards for medical use, potentially leading to improper function or injury.
Healthcare professionals using Medline convenience kits with specific syringe models and lots numbers are affected. Patients receiving care from these kits may be at risk if the syringes are used improperly.
Check for the product codes: ARTERIOGRAM TRAY 00-402001T or 00-402001U, and specific lot numbers listed in the recall notice. The kits are sold under Medline's convenience kit labels.
Look for the product codes and lot numbers listed in the recall notice to confirm if your kit is affected.
The products have unapproved design changes outside of the FDA's 510(k) clearance process, which means they may not meet required safety standards.
The recall notice does not specify a remedy, so check the product details to see if it's affected and contact Medline for further instructions.
Yes, specific lot numbers are listed in the recall notice, but the notice does not provide a list of all affected lots for the general public.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1891-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1891-2026 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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