Medline recalls convenience kits with select 10mL polycarbonate colored syringes due to 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 because they were made with design changes not approved by the FDA. This could lead to safety issues if the syringes are used without proper regulatory clearance.
The syringes were made with design changes that the FDA did not approve through the 510(k) clearance process. This means they might not meet safety standards, potentially causing issues during medical use.
Healthcare professionals and individuals who use these syringes for medical purposes may be affected. Those using the recalled kits with specific model numbers and lots are at risk.
Check for the model numbers listed: DYNJ34846C, DYNJ83218A, DYNJ85396, DYNJ905156R, DYNJ905159L, DYNJ905159M, DYNJ69926A, DYNJ41250B. Also look for the lot numbers mentioned in the recall notice.
Identify the model numbers and lot numbers listed in the recall notice to confirm if your kit is affected.
The products were made with design changes not approved by the FDA through the 510(k) clearance process.
Affected model numbers include DYNJ34846C, DYNJ83218A, DYNJ85396, DYNJ905156R, DYNJ905159L, DYNJ905159M, DYNJ69926A, and DYNJ41250B.
Check the model numbers and lot numbers listed in the recall notice to see if your kit matches the affected items.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1887-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1887-2026 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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