Recall archive / FDA device enforcement
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair , — FDA record Z-1612-2023
Reported ongoing
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 Apr 14, 2023. 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 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,
- Reason
- Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
- Classification
- Class II
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 50 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1612-2023
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 # 0000157564, UDI-DI: 00885825013585 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: WA 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
- May 24, 2023
- Recall initiation date
- Apr 14, 2023
- Center classification date
- May 19, 2023
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.