Surgical Suture Kit — Class II medical device recall Z-1132-2022
Completed recall by Stradis Healthcare, reported 2022-06-01, distributed in NC. There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
| Recall number | Z-1132-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Healthcare, Waukegan, IL, United States |
| Recall initiated | 2022-04-22 |
| Classified | 2022-05-25 |
| Reported by FDA | 2022-06-01 |
| Distributed | NC |
| Quantity | 7,340 units |
| Reason classes | sterility |
| Lot numbers | 212675717, 212957814, 213639474 |
| Model numbers | ZZ-0958 |
Product
Surgical Suture Kit
Reason for recall
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
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-1132-2022. 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.