Official recall notice
FDA DeviceClass IINotable
FDA Recall: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5
- Recall date
- 2026-04-15
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Recommended action
What to do
56,740 cuffs
Product description
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.