Medline Industries LP recalls 30+ medical kits including newborn admission and drainage trays due to rescinded 510(k) regulatory clearances. Affected units have specific model numbers and lot numbers.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries LP has recalled 30+ medical kits, including newborn admission and drainage trays, because the FDA rescinded their regulatory clearances. This means the products may not be safe for use in medical procedures.
The recall is based on the FDA rescinding the 510(k) regulatory clearances for certain medical devices. This means the products were no longer approved for use in medical procedures, potentially leading to safety issues if used.
Healthcare providers and medical facilities that own or use these kits are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
Check for model numbers listed in the recall (e.g., DYKB1038, DYNDA3188) and lot numbers (e.g., 22GBJ869) on the product packaging or documentation.
Identify the model number and lot number on the product to confirm if it is affected by this recall.
The FDA rescinded the 510(k) regulatory clearances for certain medical devices, meaning the products were no longer approved for use in medical procedures.
The recall includes 30+ medical kits with specific model numbers and lot numbers, such as newborn admission kits (model DYKB1038) and drainage trays (model DYNDA3188).
The recall does not specify a stop-use instruction, so users should check the product details to confirm if it is affected before taking action.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1842-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1842-2026 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.
