Medline recalls convenience kits with select 10mL polycarbonate colored syringes that have 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 containing specific 10mL polycarbonate colored syringes due to unapproved design changes that were not cleared by the FDA. These products were not initially reported in RES 98601.
The syringes have unapproved design changes that were not cleared by the FDA. This means they may not meet safety standards for medical use, but the recall does not specify how this could cause harm in normal use.
Healthcare professionals and medical facilities that use these syringes for procedures like vascular access, imaging, or interventions. Those handling the specific model numbers listed in the recall are most at risk.
Check for the product names listed in the recall, such as 'ABDOMINAL VASCULAR-LF', 'CVICU HEART BAG', and other specific syringe kits. Look for the model numbers like DYNJ905291B, DYNJ28082G, and the lot numbers provided.
Identify if your syringes match the specific model numbers and lot numbers listed in the recall notice.
The products have unapproved design changes that were not cleared by the FDA and were not initially reported in RES 98601.
Check the product details against the model numbers and lot numbers listed in the recall to see if they are affected.
The recall states the syringes have unapproved design changes not cleared by the FDA, but it does not specify how this could cause harm in normal use.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2593-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2593-2026 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.
