8mm FlexDex Needle Driver — Class II medical device recall Z-0531-2022
Terminated recall by FlexDex Inc., reported 2022-02-02. The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of th
| Recall number | Z-0531-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | FlexDex Inc., Brighton, MI, United States |
| Recall initiated | 2021-12-22 |
| Classified | 2022-01-27 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2023-07-25 |
| Quantity | 273 |
| Lot numbers | 8MM |
Product
8mm FlexDex Needle Driver, Product Code FD-335 ND
Reason for recall
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
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-0531-2022. 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.