Medline is recalling convenience kits containing select 10mL polycarbonate colored syringes due to unapproved design changes not reported to 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 specific convenience kits that include certain 10mL polycarbonate colored syringes. These products have unapproved design changes that were not initially reported to the FDA, which could pose a risk to patient safety.
The syringes have design changes that were not approved by the FDA and were not initially reported in the required regulatory documentation. This could lead to improper use or failure during medical procedures, potentially causing harm to patients.
Healthcare professionals and patients using the recalled syringes for medical procedures. Those most at risk are individuals who have received the specific kits listed in the recall.
Check for the product names and model numbers listed in the recall, such as DYNJ905153J, DYNJ905153K, DYNJ905153L, and others. The kits were sold with specific lot numbers and UDI-DI codes.
Identify the specific model numbers and lot numbers listed in the recall to determine if your kit is affected.
The syringes have unapproved design changes that were not initially reported to the FDA, which could lead to improper use or failure during medical procedures.
Check for the specific model numbers and lot numbers listed in the recall, such as DYNJ905153J, DYNJ905153K, DYNJ905153L, and others.
The recall does not specify a remedy, so contact Medline directly for guidance on next steps.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2583-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2583-2026 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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