Medline recalls GYN Laparoscopy Packs with model DYNJ41257F due to rescinded 510(k) regulatory clearances. Affected units include specific lot numbers and UDI-DI codes.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling GYN Laparoscopy Packs with model number DYNJ41257F because regulatory clearances for certain medical components have been rescinded. This means the products may not meet safety standards and could pose risks during medical procedures.
The regulatory clearances for specific medical components like control syringes, guidewires, and high-pressure tubing have been rescinded. This means the products may not meet safety standards required by the FDA, potentially leading to complications during medical procedures.
Healthcare providers using the recalled GYN Laparoscopy Packs with model DYNJ41257F are most at risk. Patients undergoing procedures with these kits could be affected if the products are used without proper regulatory clearance.
Check for model number DYNJ41257F on the GYN Laparoscopy Pack. Affected units include specific lot numbers (25GBL423) and UDI-DI codes (10193489708523 and 40193489708524).
Identify the model number and lot number on the GYN Laparoscopy Pack to confirm if it is affected.
The 510(k) regulatory clearances for certain medical components have been rescinded, meaning the products may not meet safety standards.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 see if it matches the affected model and lot numbers.
The recall indicates potential safety issues due to rescinded regulatory clearances, but specific risks are not detailed in the record.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1846-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1846-2026 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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