Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack Recalled by Pro-Dex Inc Due to Visual particulates within a battery Tyvek pouch. The...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pro-Dex Inc directly.
Affected Products
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.
Quantity: 68 cases of 40 batteries = 2,720 individual batteries
Why Was This Recalled?
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pro-Dex Inc
Pro-Dex Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report