FDA Device recall Z-0531-2022
8mm FlexDex Needle Driver, Product Code FD-335 ND
- FDA Device
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of 8mm FlexDex Needle Driver, Product Code FD-335 ND by Flexdex, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0531-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-22 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Flexdex |
| Distribution | n/a |
Product
8mm FlexDex Needle Driver, Product Code FD-335 ND
Reason
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2022%22
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