Agency classClass IIOur severity:High FDA (Devices)·Z-1340-2023·Announced 2023-04-12

Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery

Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of surgical equipment with potential for serious patient harm (hemorrhage) from pressure failure during use. However, no injuries or hospitalizations have been reported, and the hazard represents a risk-of-harm scenario rather than demonstrated harm, placing it in the High severity category.

Plain-English summary

Stryker Corporation is recalling 1,206 units of the Color Cuff Non-Sterile Disposable Tourniquet Cuff (Catalog number 5921-030-235NS) used in surgical procedures to temporarily stop blood flow to a patient's extremities. Affected lot numbers are 2022111804, 2022112902, 2022121909, 2022121910, 2022122603, and 2022122604.

The cuffs may fail to achieve or maintain the desired pressure during initial setup on the patient. Two different causes for this failure have been reported. The pressure failure could result in operative site blood loss or hemorrhage, and in very rare situations, other serious complications.

The cuffs were distributed nationwide. The recall affects healthcare facilities and surgical settings where these tourniquet cuffs are used.

Healthcare providers using these cuffs should contact Stryker or their medical device supplier for instructions regarding the affected units.

The recalled product

Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
Manufacturer: Stryker Corporation
Category: Medical Device — Surgical Tourniquet
Hazard: pressure-failure
hemorrhage

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Stryker Corporation

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Same hazard · pressure failure