Medline recalls convenience kits containing select 10mL polycarbonate syringes and catheter packs with unapproved design changes outside 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that include certain 10mL polycarbonate syringes and catheter packs due to unapproved design changes that were not cleared by the FDA through the 510(k) process. This means the products were made without proper regulatory approval.
The products were made with design changes that the FDA did not approve through the 510(k) clearance process. This means they may not meet safety and performance standards, but the recall does not specify a direct hazard like injury or malfunction.
Healthcare professionals and medical facilities that own or use these specific Medline convenience kits are affected. The risk is primarily for those using the products in clinical settings.
Check for the product names and model numbers listed in the recall, such as 'ADULT CATH PACK-LF DYNJ38395G' or 'ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F'. Also look for the lot numbers and UDI-DI codes provided in the list.
Identify the specific product names and model numbers listed in the recall to confirm if your kit is affected.
The products were made with unapproved design changes outside of the 510(k) clearance process, meaning they were not properly approved by the FDA.
The recall does not specify a remedy, so you should check the product details to see if it is affected and contact Medline for further instructions.
The recall states there were unapproved design changes, but it does not describe a specific hazard like injury or malfunction.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1877-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1877-2026 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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