Medline recalls convenience kits containing specific 10mL polycarbonate syringes with unapproved design changes not cleared by the FDA. Products 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 that include certain 10mL polycarbonate colored syringes due to unapproved design changes that weren't cleared by the FDA. These kits were not initially reported in the required regulatory document.
The syringes have design changes that were not approved by the FDA through the 510(k) process. This means they might not meet safety standards for medical use, potentially leading to issues during procedures. The products were also not reported in the required regulatory document (RES 98601), which could indicate a lack of proper oversight.
Healthcare professionals using these specific syringe kits for medical procedures are most at risk. Patients receiving treatments with these kits could be affected if the syringes are used without proper regulatory approval.
Check for the model numbers DYNJ41089, DYNJ62827A, DYNJ47899A, DYNJ44123B, DYNJ68037A, or DYNJ0101291F on the kits. These kits were sold with specific lot numbers and UDI-DI codes listed in the recall notice.
Look for the model numbers DYNJ41089, DYNJ62827A, DYNJ47899A, DYNJ44123B, DYNJ68037A, or DYNJ0101291F on the kits to confirm if they are affected.
The syringes have unapproved design changes not cleared by the FDA through the 510(k) process and were not initially reported in the required regulatory document (RES 98601).
The recall notice does not specify a remedy, so check the product details to confirm if they are affected and contact Medline for further instructions.
Yes, the recall includes specific lot numbers such as 21BBB592, 24BBN289, and others listed in the product details.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2594-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2594-2026 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.
