Agency classClass IIOur severity:High FDA (Devices)·Z-1315-2023·Announced 2023-04-05

Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.

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 device recall for tourniquet cuffs with a functional defect that creates risk of hemorrhage during surgery. No specific injuries have been reported in the source text, but the risk-of-harm nature of the product defect meets the High severity criterion for products where injury has not yet been reported.

Plain-English summary

Stryker Sustainability Solutions is recalling 127,894 disposable tourniquet cuffs sold under the Color Cuff brand. The affected products include Single Port and Dual Port models in multiple sizes (18, 30, and 34 millimeters) with Quick Connect connections.

The cuffs are being recalled due to reports of increased incidence of units that cannot achieve or maintain the desired pressure required for surgical procedures. Two defects have been identified: the cuff fabric may tear during use, or the O-ring at the connection between the cuff, fill line, and hosing may become pinched or unseated.

These defects may result in loss of vascular occlusion (cessation of blood flow), potentially leading to operative site blood loss, hemorrhage, and other surgical complications. The affected cuffs have been distributed across all 50 states and the District of Columbia.

Healthcare facilities should immediately stop using the affected lot numbers and contact Stryker Sustainability Solutions regarding replacements or additional guidance.

The recalled product

Product: Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF…
Manufacturer: Stryker Sustainability Solutions
Category: Medical Device — Surgical Tourniquet
Hazard: pressure-loss
fabric-tearing
seal-failure
hemorrhage
Affected units: 127,894

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 (20)

REF/UI-DI: 5921-030-135/885825016142
5921-030-235/885825016166
5921-034-135/885825016173
5921-034-235/885825016197
5921-218-135/885825016500
5921-218-235/885825016296 Lots: 0000202775
0000209215
0000202137
0000201380
0000200708
13872322
13453772
0000198235
0000202066
0000209420
0000206425
0000192978
0000202577
0000192465
13463347

Distribution

Distributed in 50 states:

Same manufacturer · Stryker Sustainability Solutions

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Same hazard · pressure loss