Stryker Tourniquet Cuff May Fail to Hold Pressure During Surgery
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or hold pressure during initial surgical setup. This failure could allow blood to flow from the surgical site, potentially causing hemorrhage.
What this means for you
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 a Class II medical device recall involving a serious surgical hazard—failure to achieve or maintain tourniquet pressure. However, the source documents no reported injuries or illnesses, and describes potential complications as occurring in 'exceedingly rare situations.' Per the FDA rubric, this rates High (Score 3) as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling Color Cuff Non-Sterile Disposable Tourniquet Cuffs (Catalog number 5921-030-135NS) used in surgical procedures to temporarily block blood flow to patients' extremities. The recall affects 1,225 units distributed nationwide in the United States.
The tourniquet cuffs may fail to achieve or maintain the desired pressure during initial setup. This defect could result in operative site blood loss, hemorrhage, or in rare cases, other serious complications during surgical procedures.
The affected lot numbers are: 2022111803, 2022112901, 2022121911, 2022121912, 2022122601, and 2022122602. These products were distributed to healthcare facilities across the United States.
Healthcare providers should verify the lot numbers of their tourniquet cuff inventory and check for the affected units. The FDA and Stryker Corporation have issued this recall to alert healthcare providers to the potential risk associated with these products.
The recalled product
- Product
- Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
- Manufacturer
- Stryker Corporation
- Hazard
- pressure-failure
- hemorrhage
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 (2)
- GTIN: 07613327606157 Lot Numbers
- 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602
Distribution
Distributed nationwide across the United States.
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