Medline Industries recalls heart transplant biopsy kits with model DYNJ37543A due to rescinded 510(k) regulatory clearances. Affected kits may pose safety risks requiring immediate action.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline is recalling heart transplant biopsy kits with model number DYNJ37543A because regulatory clearances for certain components have been rescinded. This means the kits could be unsafe and should not be used until a replacement is obtained.
The recall is due to the rescission of 510(k) regulatory clearances for certain components like control syringes, guidewires, and high-pressure tubing. This means the products no longer meet safety standards and could pose risks during medical procedures.
Healthcare professionals using heart transplant biopsy kits with model DYNJ37543A are likely affected. Those in medical settings handling these specific kits are at the highest risk.
Check for the model number DYNJ37543A on the kit. The lot number 24DDA193 and UDI-DI numbers 10193489919561 (each) and 40193489919562 (case) are also associated with this recall.
Verify the model number DYNJ37543A and lot number 24DDA193 on the kit to confirm it is affected.
The 510(k) regulatory clearances for certain components like control syringes, guidewires, and high-pressure tubing have been rescinded, meaning the kits no longer meet safety standards.
The recall record does not specify a remedy, so contact Medline directly for guidance on next steps.
Look for the model number DYNJ37543A and lot number 24DDA193 on the kit.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1838-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1838-2026 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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