Class II — Pro-Dex Inc
| Recalling firm | PRO-DEX, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. |
| 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 exemp… |
| 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. |
| Initiated | 2018-09-25 |
| Classified | 2019-08-22 |
| Terminated | 2022-04-20 |
| Recall number | Z-2340-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Pro-Dex Inc (Z-2340-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83113/
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