Ct Biopsy Tray
Recall Summary Medline's Heart Transplant Biopsy Kit (Model DYNJ37543A) is being recalled nationwide because certain components—including control syringes, guidewires, and high-pressure tubing—no longer have valid FDA regulatory clearances. The recall affects hospitals and medical facilities across all U.S. states that have received this product.
- Product
- Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
- Reason
- The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d30b5271-12ed-4efe-9d5d-5137214c68d2