Medline recalls convenience kits containing specific 10mL polycarbonate colored syringes with unapproved design changes not cleared by FDA. Affected kits include CRANIOTOMY PACK-LF and others with model numbers DYNJ0101292F through DYNJ30150F.
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 contain certain 10mL polycarbonate colored syringes. These syringes have unapproved design changes that were not initially reported to the FDA, which could pose a risk if used without proper regulatory approval.
The syringes have design changes that were not approved by the FDA through the 510(k) process and were not initially reported in the required regulatory documentation. This means they may not meet safety standards for medical use, potentially leading to complications during procedures.
Healthcare professionals and medical facilities that use these specific syringe kits are likely affected. Patients using these syringes for procedures like craniotomy or spinal surgery may be at risk if the unapproved design causes issues.
Check for convenience kits with model numbers listed in the recall, such as CRANIOTOMY PACK-LF (DYNJ0101292F, DYNJ0101292G), HYBRID PACK (DYNJ65925A), and others. The kits were sold with specific lot numbers and UDI-DI codes.
Look for the model numbers and lot numbers listed in the recall to confirm if your kit is affected.
The syringes have unapproved design changes that were not initially reported to the FDA, which means they may not meet safety standards for medical use.
Convenience kits containing specific 10mL polycarbonate colored syringes with model numbers like DYNJ0101292F, DYNJ65925A, DYNJ905156L, and others are affected.
The recall does not specify a stop-use action, so you should check the product details to confirm if your kit is affected before taking any action.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2587-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2587-2026 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.
