Tenaculum — Class II medical device recall Z-0126-2022
Ongoing recall by Stradis Medical, LLC dba Stradis Healthcare, reported 2021-10-27, distributed nationwide. Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufac
| Recall number | Z-0126-2022 |
|---|---|
| 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 | 2021-09-10 |
| Classified | 2021-10-16 |
| Reported by FDA | 2021-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 2,483 kits |
| Model numbers | 356T |
Product
Tenaculum, Plastic
Reason for recall
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
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-0126-2022. 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.