Stryker Color Cuff tourniquet cuff mislabeled as single-bladder when dual-bladder
Stryker Sustainability Solutions is recalling 40 units of Color Cuff 18" tourniquet cuffs (Lot #12983349) because they are mislabeled as single-bladder when they are actually dual-bladder, creating a risk of incorrect clinical use.
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: FDA Class II device with a functional mislabeling defect affecting a critical component (single vs. dual bladder). This is a risk-of-harm product where injury has not yet been reported, but the mislabeling of a tourniquet cuff creates potential for incorrect clinical use.
Plain-English summary
Stryker Sustainability Solutions is recalling 40 units of its Stryker Color Cuff 18" (Red) Quick Connect tourniquet cuff, reference number 5921-018-135 (Lot #12983349). The cuffs are mislabeled as single-bladder inflatable cuffs when they are actually dual-bladder.
This mislabeling creates a risk of incorrect use in clinical and surgical settings where the bladder configuration is critical for proper device function and patient safety. Users relying on the labeling may deploy or use the cuff incorrectly.
The affected units were distributed in Kansas, Oklahoma, and Texas. If you have received this lot number, contact Stryker Sustainability Solutions immediately for return instructions or product replacement.
The recalled product
- Product
- REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 40
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)
- Lot # 12983349
Distribution
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