FDA Medical Device Recalls (openFDA)
FlexDex Inc.: 8mm FlexDex Needle Driver, Product Code FD-335 ND
- Recall number
- Z-0531-2022
- Recalling firm
- FlexDex Inc.
- Product
- 8mm FlexDex Needle Driver, Product Code FD-335 ND
- Status
- Terminated
- Initiated
- 2021-12-22
- Posted
- not on file
- Terminated
- 2023-07-25
- 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.
- Root cause
- Unknown/Undetermined by firm
- Action
- The firm sent a letter to customers reiterating the IFU's statement "Do not use if package is damaged." This is important to ensure the sterility of the product. If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. Please forward this letter on to all those who need to be aware within your organization and to any other organizations (e.g. customers) on which this has an impact.
- Quantity
- 273
- Distribution
- n/a
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 3012046682
- Firm city
- Brighton
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28