Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure
Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or 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: The source text describes a risk-of-harm device malfunction but explicitly states the potential for complications occurs 'in exceedingly rare situations' and does not report any actual injuries or illnesses. This meets the rubric criterion for Score 3 (High): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 1,617 units (supplied in packs of 10) of the Color Cuff Non-Sterile Disposable Tourniquet Cuff, catalog number 5921-034-235NS. This medical device is designed for use in surgical procedures that require temporary reduction of blood flow to a patient's extremities.
The company identified two separate failure modes in which the cuff may not achieve the desired pressure level or may fail to maintain pressure during initial setup on the patient. These malfunctions could result in operative site blood loss, hemorrhage, or in exceedingly rare situations, other major complications.
The affected cuffs were distributed nationwide. Affected lot numbers include: 2022111806, 2022112802, 2022120501, 2022120502, 2022120503, 2022120504, 2022120505, and 2022120701. Healthcare facilities using affected units should stop using them and contact Stryker Corporation for replacement or additional information.
The recalled product
- Product
- Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
- Manufacturer
- Stryker Corporation
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.
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