FDA DeviceClass IINotable

FDA Recall: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5

Date: 2026-04-15
Brand: Stryker Sustainability Solutions
Category: Medical Device
FDA Class: Class II

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.

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.

Remedy

56,740 cuffs

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