FDA Medical Device Recalls (openFDA)
Pro-Dex Inc: PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
- Recall number
- Z-2340-2019
- Recalling firm
- Pro-Dex Inc
- Product
- PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
- Status
- Terminated
- Initiated
- 2018-09-25
- Posted
- not on file
- Terminated
- 2022-04-20
- Reason
- Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
- Root cause
- Under Investigation by firm
- Action
- On 09/25/2018, the firm sent an "URGENT" notification to customers via email and followed up with a (USPS) letter on 09/26/2018 informing them that certain lots of sterile batteries may have visible particulates within the battery Tyvek pouch. Customers were advised to 1) "immediately cease distribution and use of these lots, and 2) Inventory and distribution records should be evaluated immediately to ensure that affected product is removed from any potential point of use". Customers are instructed to return products to: Returns Department (Recall complaint C18-061 Pro-Dex, Inc. 2361 McGaw Avenue Irvine, CA 92614 USA and to reference the Recall Complaint #C18-061 on the outside of the shipping box. If the customers have any questions or concerns to contact the QARA group at 949 769 3200.
- Quantity
- 68 cases of 40 batteries = 2,720 individual batteries
- Distribution
- Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
- Lot, serial or model codes
- PDBP-001 Series Model: PDBP-040-2 (40ct PDBP-001-2) which are 40 count batteries. Lot(s): K098N (61900), K0B3F (62625) K098N and K0B3F are Pro-Dex lot numbers. 61900 and 62625 are the contract packager's lot numbers UDI Code: (01) 0 0860540 00025 6
- 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