Official recall notice
FDA DeviceClass IINotable
FDA Recall: Sterile Radiology Procedure Kits, Model Number DYNDH1491B
- Recall date
- 2026-04-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Recommended action
What to do
420 units
Product description
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.