Medline recalls specific craniotomy packs (models DYNJ32841F, DYNJ46069D) as 510(k) regulatory clearances were rescinded, posing potential safety risks.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling certain craniotomy packs and medical kits because the U.S. regulatory clearances for some components were rescinded. This means the products may not meet safety standards and could pose risks during medical procedures.
The 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. This means the products may not meet the required safety standards for medical use, potentially leading to complications during surgical procedures.
Healthcare professionals and medical facilities that use these specific craniotomy packs and kits are most at risk. Patients using these products during surgery could be affected if the components are not properly regulated.
Check for model numbers DYNJ32841F, DYNJ46069D, DYNJ51935A, DYNJ68902A, DYNJ80679A, DYNJ82370A, or DYNJ84272 on the product. Also look for lot numbers like 24CBF407, 24KBG704, or 24BME364.
Identify the model number and lot number on the product to confirm if it is recalled.
The 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded, meaning the products may not meet safety standards.
The recall record does not specify a remedy, so check the product details to confirm if it is recalled and contact Medline for further instructions.
Yes, the affected models include DYNJ32841F, DYNJ46069D, DYNJ51935A, DYNJ68902A, DYNJ80679A, DYNJ82370A, and DYNJ84272.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1849-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1849-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
