Medline recalls convenience kits containing unapproved 10mL polycarbonate colored syringes due to design changes outside FDA clearance. Affected kits include specific model numbers and lots. Consumers should check their kits for listed serial numbers.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that include certain 10mL polycarbonate colored syringes because they were made with design changes not approved by the FDA. This could pose a safety risk if the syringes are used without proper 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 for medical use, potentially leading to issues if used improperly.
People who own or use Medline Convenience Kits with the specific syringe models and lots listed in the recall notice are affected. Those most at risk are healthcare professionals using these syringes for medical procedures.
Check your Medline Convenience Kits for syringes labeled with model numbers DYNJ0101278F, DYNJ0101278G, or DYNJ0101278I. Also look for specific lot numbers listed in the recall notice, such as 22CDB133 or 24JDC169.
Look for model numbers DYNJ0101278F, DYNJ0101278G, or DYNJ0101278I on the syringes in your Medline Convenience Kits.
Check the lot numbers listed in the recall notice, such as 22CDB133 or 24JDC169, to confirm if your kit is affected.
The syringes were made with design changes not approved by the FDA through the 510(k) clearance process, which could pose a safety risk.
Affected models include DYNJ0101278F, DYNJ0101278G, and DYNJ0101278I with specific lot numbers listed in the recall notice.
The recall does not require immediate discontinuation; you can check if your kit is 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-1880-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1880-2026 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.
