Recall archive / FDA device enforcement
8mm FlexDex Needle Driver, Product Code FD-335 ND — FDA record Z-0531-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 22, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- FlexDex Inc.
- Quantity
- 273
- Agency-reported status
- Terminated
- Source record identifier
- Z-0531-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 2, 2022
- Recall initiation date
- Dec 22, 2021
- Center classification date
- Jan 27, 2022
- Termination date
- Jul 25, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.