Medline recalls convenience kits with select 10mL polycarbonate colored syringes that have unapproved design changes not cleared by the FDA. Products were not initially reported in RES 98601.
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 were not cleared by the FDA. This recall affects products not initially reported in RES 98601, which could pose risks if used without proper regulatory approval.
The syringes have unapproved design changes that were not cleared by the FDA. This means they may not meet safety standards for medical use, potentially leading to improper function or harm during procedures. The products were not initially reported in RES 98601, which could indicate a lack of proper regulatory oversight.
Healthcare professionals and medical facilities that use these syringes are likely affected. The risk is higher for users who rely on these products for critical medical procedures.
Check for the product codes listed in the recall notice: DYNJ85743, DYNJ81610C, DYNJ0843063L, DYNJ54755J, DYNJ61383C, DYNJ0843339O, DYNJ61907A, DYNJ0429121L. These syringes were sold in specific lots and with certain UDI-DI numbers.
Identify the product codes and lots listed in the recall notice to confirm if your syringes are affected.
These syringes have unapproved design changes not cleared by the FDA and were not initially reported in RES 98601.
Check the product codes and lots listed in the recall notice to determine if your syringes are affected.
The recall indicates unapproved design changes that may not meet FDA safety standards, but specific risks are not detailed in the notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2590-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2590-2026 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.
