Medline Industries LP recalls 51 left heart kits and related medical supplies due to rescinded 510(k) regulatory clearances for control syringes, guidewires, and high-pressure tubing.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries LP has recalled 51 different left heart kits and related medical supplies because the U.S. FDA rescinded the regulatory clearances for certain control syringes, guidewires, and high-pressure tubing used in these kits. This means the products may not be safe for medical use.
The recall is due to the FDA rescinding the 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing. This means these components may not meet safety standards for medical use, potentially leading to unsafe medical procedures.
Healthcare facilities and medical professionals who own or use the recalled left heart kits and related supplies are most at risk. The specific models and lot numbers are listed in the recall notice.
Check the model numbers and lot numbers listed in the recall notice. The affected kits include specific models like 60021775, 60022026, and others with corresponding lot numbers.
Identify the model number and lot number of your left heart kit or related medical supplies to confirm if it is affected.
The FDA rescinded the 510(k) regulatory clearances for certain control syringes, guidewires, and high-pressure tubing used in these kits, meaning they may not meet safety standards.
Check the model number and lot number of your product against the list provided in the recall notice to determine if it is affected.
The recall is due to the FDA rescinding regulatory clearances, which means the products may not be safe for medical use, but specific safety risks are not detailed in the notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1836-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1836-2026 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.
