Medline recalls convenience kits containing select 10mL polycarbonate colored syringes due to unapproved design changes not reported to FDA.
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 that include certain 10mL polycarbonate colored syringes. These products have unapproved design changes that were not initially reported to the FDA, which could pose a risk 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 reported in the required regulatory documentation. This means they may not meet safety standards for medical use.
Healthcare professionals using these syringes for medical procedures are most at risk. Patients receiving treatments with these syringes could be affected if the design changes impact safety.
Check for convenience kits with product codes like DYNJ0854485S, DYNJ0842793G, DYNJ55385A, and other listed model numbers. These kits were sold with specific lot numbers and UDI-DI codes.
Look for the product codes and lot numbers listed in the recall notice to confirm if your kit is affected.
The syringes have unapproved design changes that were not initially reported to the FDA, which could affect their safety for medical use.
Check for the specific product codes and lot numbers listed in the recall notice, such as DYNJ0854485S or DYNJ0842793G.
The recall notice does not specify a remedy, so contact Medline directly for guidance.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2586-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2586-2026 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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