PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery… — Class II medical device recall Z-2340-2019
Terminated recall by Pro-Dex Inc, reported 2019-08-28, distributed nationwide. Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical driver
| Recall number | Z-2340-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pro-Dex Inc, Irvine, CA, United States |
| Recall initiated | 2018-09-25 |
| Classified | 2019-08-22 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2022-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | FI |
| Reason classes | sterility, specification failure |
| Lot numbers | 00025, 0860540, 61900, 62625, K098N, K0B3F |
| Model numbers | PDBP-040-2 |
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.
Reason for recall
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2340-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.