Agency classClass IIOur severity:High FDA (Devices)·Z-0593-2020·Announced 2019-12-11

Stryker Recalls Disposable Tourniquet Cuffs Due to Air Leak Risk

Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.

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: The recall involves a medical device with a functional defect that could lead to a loss of vascular occlusion during surgery. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 16,380 units of the Color Cuff Disposable Tourniquet Cuff, Product Number 5921-018-235. The affected product is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient's extremities to produce greater visualization of the operative field.

The recall is being issued because there is a potential for the cuff to leak air, which could lead to a loss of vascular occlusion. This failure could compromise the surgical procedure by failing to maintain the necessary blood flow restriction.

The affected units were distributed worldwide, including nationwide in the United States and in Argentina, Australia, Canada, and the Netherlands. The specific lot numbers involved are 60180374 and 60181194. Healthcare facilities and consumers should stop using these specific products and contact Stryker for further instructions.

The recalled product

Product: Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the…
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Surgical Instruments
Hazard: air-leak
loss-of-vascular-occlusion
Affected units: 16,380

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

GTIN: 37613154599296
Lot Numbers 60180374
60181194

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Stryker Instruments Div. of 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 2 products in this recall →

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · air leak