Medline recalls convenience kits containing specific 10mL polycarbonate colored syringes due to unapproved design changes not cleared by the 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 because they have unapproved design changes not cleared by the FDA. This could mean the products were not properly tested for safety before being sold.
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 if used improperly.
Healthcare workers and others who use these syringes for medical purposes may be affected. Those handling the specific kits with the model DYNJ54603B are most at risk.
Check for the model number DYNJ54603B on the convenience kit. The kits were sold with lot number 24ABO124 and have a UDI-DI code 10195327458188.
Look for the model number DYNJ54603B and lot number 24ABO124 on the convenience kit.
The products have unapproved design changes not cleared by the FDA through the 510(k) process, meaning they were not properly tested for safety.
The recall record does not specify a remedy, so there is no action required beyond checking if you have the specific model.
The recall indicates unapproved design changes, but the specific safety risks are not detailed in the record.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2596-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2596-2026 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.
