FDA Medical Device Recalls (openFDA)
Pro-Dex Inc: KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
- Recall number
- Z-0280-2025
- Recalling firm
- Pro-Dex Inc
- Product
- KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
- Status
- Open, Classified
- Initiated
- 2024-09-23
- Posted
- 2024-10-31
- Terminated
- not on file
- Reason
- The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
- Root cause
- Component design/selection
- Action
- On 9/23/24, an "URGENT" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following: 1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use. 2) Product should be returned to the recalling firm. 3) The Recall Acknowledgement and Return Form should be completed and returned via email to Recall@Pro-Dex.com or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or Recall@Pro-Dex.com
- Quantity
- 2000
- Distribution
- US distribution to FL only.
- Lot, serial or model codes
- Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MOQ
- Firm FEI
- 2081135
- Firm city
- Irvine
- Firm state
- CA
- 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