Medline recalls convenience kits with select 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 containing specific 10mL polycarbonate colored syringes because they have unapproved design changes that weren't reported to the FDA. This could pose a risk if the syringes aren't properly cleared for medical use.
The syringes have design changes that weren't approved by the FDA and weren't initially reported in the required regulatory documentation. This means they might not meet safety standards for medical use.
Healthcare professionals using these syringes in medical procedures are most at risk. Patients receiving treatments with these syringes could be affected if the design changes impact safety.
Check for the product names listed in the recall notice, including specific model numbers like DYNJ905651B and ARTERIOGRAM TRAY. Look for lot numbers such as 24BME750 or 21ABV063.
Identify the specific model numbers and lot numbers listed in the recall notice to confirm if your syringes are affected.
The syringes have unapproved design changes that weren't cleared by the FDA and weren't initially reported in the required regulatory documentation.
Check for the specific model numbers and lot numbers listed in the recall notice, such as DYNJ905651B or lot 24BME750.
The recall notice does not specify a remedy, so you should check the product details to confirm if your syringes are affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2585-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2585-2026 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.
