Stryker Tourniquet Cuffs Recalled for Mislabeling Port Configuration
Stryker is recalling 450 reprocessed tourniquet cuffs because they were mislabeled regarding their port configuration.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Sustainability Solutions is recalling 450 units of reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs. The devices are indicated for use in patients who require surgery of the extremities.
The recall was initiated because the devices were mislabeled. Specifically, some cuffs were labeled as single port when they contained dual ports, and vice versa. The affected model numbers are 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, and 5921-024-236.
The devices were distributed nationwide, including in Alaska, Nevada, Vermont, Florida, California, Colorado, Wisconsin, Iowa, Minnesota, Oklahoma, Pennsylvania, Michigan, Oregon, Kentucky, and Massachusetts. Healthcare facilities should stop using the affected devices and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 450
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 (1)
- 4002152 Model #5921-044-135 Lot #3759409 Model #5921-024-236 Lot #3822485
Distribution
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