Medline recalls convenience kits containing 10mL polycarbonate colored syringes with unapproved design changes not cleared by the FDA. Affected kits may not have been 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. These syringes have unapproved design changes that weren't cleared by the FDA and weren't initially reported in RES 98601.
The syringes have design changes that weren't approved by the FDA through the 510(k) process. This means they might not be safe for medical use as intended, but the specific risk isn't detailed in the recall notice.
Healthcare professionals using these syringes for medical procedures are likely affected. Those who purchased the kits from medical suppliers or hospitals are most at risk.
Check for kits labeled with 'ANGIOGRAM PACK-LF' and model numbers DYNJ21574J or DYNJ51126. These kits were sold with specific lot numbers like 21ALA586 through 21HLA420.
Look for the model numbers DYNJ21574J or DYNJ51126 on the kit label.
The syringes have unapproved design changes that weren't cleared by the FDA through the 510(k) process and weren't initially reported in RES 98601.
The recall notice doesn't specify a remedy, so contact Medline directly for guidance.
Yes, affected kits include lot numbers 21ALA586 through 21HLA420.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2581-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2581-2026 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.
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