Recall archive / FDA device enforcement
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder — FDA record Z-0664-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
- Reason
- Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
- Classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 40 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0664-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # 12983349 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: KS OK TX OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 2, 2022
- Recall initiation date
- Jan 21, 2022
- Center classification date
- Feb 22, 2022
- Termination date
- Feb 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.