Medline recalls convenience kits containing certain 10mL polycarbonate colored syringes due to unapproved design changes not reported to FDA. Affected kits include specific model numbers and lots.
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 contain specific 10mL polycarbonate colored syringes because they have unapproved design changes not initially reported to the FDA. This could pose a risk if the syringes are 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 initially reported in the required regulatory documentation. This means they may not meet safety standards for medical use.
Healthcare professionals and medical facilities that use these convenience kits for procedures requiring syringes. Those handling the specific model numbers and lots listed in the recall are most at risk.
Check for the model numbers listed in the recall, such as DYNJ30565C, DYNJ32555B, and other specific codes. Also look for the lot numbers and UDI-DI identifiers mentioned in the record.
Review the model numbers and lot numbers on the syringes to confirm if they match the recalled items listed in the notice.
The syringes have unapproved design changes that were not initially reported to the FDA, which could affect their safety and regulatory compliance.
The affected models include DYNJ30565C, DYNJ32555B, DYNJ0774765U, and other specific codes listed in the recall notice.
The recall does not specify a stop-use instruction, so you should check the product details to confirm if your syringes are affected before taking action.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2591-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2591-2026 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.
