FDA DevicesClass II
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Published: April 29, 2026Recall ID: Z-1838-2026Category: devicesCountry: US
Reason for Recall / Hazard
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Product Description & Identification
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Affected Products
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98599 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | 1) DYNJ37543A, UDI-DI: 10193489919561(each), 40193489919562(case), Lot Number: 24DDA193 |
| Postal code | 60093-2753 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 39 units |
| Reason for recall | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260225 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.