Medline recalls convenience kits containing select 10mL polycarbonate colored syringes with unapproved design changes outside 510(k) clearance. Affected kits include specific model numbers and lots.
Unapproved design changes to the products outside of the 510(k) clearance.
Medline is recalling convenience kits that contain certain 10mL polycarbonate colored syringes due to unapproved design changes not cleared by the FDA. This could pose a risk if the syringes are used without proper regulatory approval.
The syringes have unapproved design changes that were not cleared by the FDA through the 510(k) process. This means they may not meet safety standards for medical use, potentially leading to improper function or injury if used without regulatory approval.
Healthcare professionals and medical facilities that use Medline Convenience Kits with the listed syringe models and lots are most at risk. The recall affects specific product batches sold between 2023 and 2026.
Check for the specific model numbers listed in the recall, such as DYNJ69246B, DYNJ905291D, and other codes. Look for the lot numbers mentioned, like 25EBM356 or 24JBO127, on the packaging.
Identify the model numbers and lot numbers on the syringe packaging to confirm if your kit is affected.
The recall is due to unapproved design changes to the syringes outside of the 510(k) clearance process, which means they were not properly approved by the FDA.
Check the model numbers and lot numbers listed in the recall notice, such as DYNJ69246B with lot 25EBM356 or DYNJ905291D with lots 24JBO127 and 24LBJ199.
The recall does not specify a remedy, so contact Medline directly to determine next steps for affected products.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1878-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1878-2026 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.
