FDA DevicesClass II
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Published: April 8, 2026Recall ID: Z-1693-2026Category: devicesCountry: US
Reason for Recall / Hazard
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Product Description & Identification
Sterile Radiology Procedure Kits, Model Number DYNDH1491B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98529 |
| Address 1 | 3 Lakes Dr |
| Code info | UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924 |
| Postal code | 60093-2753 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 420 units |
| Reason for recall | There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260218 |
| Initial firm notification | Letter |
| Center classification date | 20260327 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of MN.