Coryell Memorial Hosp Total — Class II medical device recall Z-0866-2022
Ongoing recall by Stradis Medical, LLC dba Stradis Healthcare, reported 2022-04-13, distributed nationwide. The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
| Recall number | Z-0866-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA, United States |
| Recall initiated | 2022-02-25 |
| Classified | 2022-04-04 |
| Reported by FDA | 2022-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 348 units |
| Reason classes | sterility |
| Lot numbers | 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822 |
| Model numbers | 690-260 |
Product
Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Reason for recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
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-0866-2022. 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.