REF 5065 — Class II medical device recall Z-1612-2023
Ongoing recall by Stryker Sustainability Solutions, reported 2023-05-24. Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Slee
| Recall number | Z-1612-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2023-04-14 |
| Classified | 2023-05-19 |
| Reported by FDA | 2023-05-24 |
| Quantity | 50 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00885825013585 |
| Lot numbers | 0000157564 |
| Model numbers | 5065 |
Product
REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Reason for recall
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1612-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.