Medline recalls convenience kits with select 10mL polycarbonate colored syringes that have unapproved design changes not reported to the FDA, potentially causing safety issues.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Medline is recalling convenience kits containing specific 10mL polycarbonate colored syringes because they have unapproved design changes that weren't initially reported to the FDA. This could lead to safety risks if used without proper regulatory approval.
The syringes have design changes that were not approved by the FDA through the 510(k) process and were not initially reported in the required regulatory documentation. This means they might not meet safety standards for medical use.
Healthcare professionals and medical facilities that own or use these specific syringe kits are likely affected. Those using the recalled kits for procedures like angiography or catheterization may be at risk.
Check for convenience kits labeled with the product names like ANGIO DRAPE PACK (ADLUG)642-LF or similar. Look for the unique identifiers (UDI-DI numbers) and lot numbers listed in the recall notice.
Identify the specific syringe kits by checking the product names and unique identifiers (UDI-DI numbers) and lot numbers listed in the recall notice.
The products have unapproved design changes that were not initially reported to the FDA, which could lead to safety risks if used without proper regulatory approval.
Check for convenience kits labeled with specific product names like ANGIO DRAPE PACK (ADLUG)642-LF and look for the unique identifiers (UDI-DI numbers) and lot numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact Medline directly to determine next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2592-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2592-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
