FDA Medical Device Recalls (openFDA)
Pro-Dex Inc: KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
- Recall number
- Z-2098-2023
- Recalling firm
- Pro-Dex Inc
- Product
- KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
- Status
- Open, Classified
- Initiated
- 2023-02-15
- Posted
- 2023-07-05
- Terminated
- not on file
- Reason
- Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
- Root cause
- Error in labeling
- Action
- On 2/15/23, a recall notice was sent to a customer asking them to cease distribution and return affected product to the recalling firm. Questions can be directed to 949-769-3200.
- Quantity
- 2000
- Distribution
- US: FL
- Lot, serial or model codes
- REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEY
- 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