Medline recalls convenience kits containing select 10mL polycarbonate colored syringes with unapproved design changes outside 510(k) clearance. Affected kits include specific model numbers and lots.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that contain certain 10mL polycarbonate colored syringes due to unapproved design changes not cleared by the FDA. This could pose a risk if the products are used 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 the products might not be safe for use as intended without proper regulatory approval.
Healthcare professionals using Medline convenience kits with specific model numbers and lots of 10mL polycarbonate colored syringes are affected. The risk is highest for those using the products without the required FDA clearance.
Check for model numbers listed in the recall, such as DYNJ0429339L, DYNJ0429339M, and specific lots like 24BMG223. The products are sold under Medline Convenience Kits.
Identify the model number and lot number on the product to see if it matches the recalled items listed in the notice.
The products have unapproved design changes outside the 510(k) clearance process, which means they were not approved by the FDA for safety and effectiveness.
Check the model number and lot number on the product to see if it matches the recalled items. If it does, contact Medline for further instructions.
The products were not approved by the FDA through the 510(k) clearance process, which could pose a risk if used without proper regulatory approval.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1890-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1890-2026 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.
