Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 28, 2019
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 dr
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pro-Dex Inc recalled PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch … - a moderate-severity action.
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch … was recalled by Pro-Dex Inc in August 28, 2019. Reason: Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical driv…. Check the official notice for the remedy. Verify recall #Z-2340-2019 with the FDA Devices before acting.
The recall
Pro-Dex Inc issued this moderate-severity FDA Devices recall-Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical driv….
- Moderate
- severity level
- Class II
- classification
- August 28, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2340-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2340-2019) was formally reported on August 28, 2019, with the manufacturer initiating the action on September 25, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Pro-Dex Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 68 cases of 40 batteries = 2,720 individual batteries.
The documented reason for this recall is: Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
68 cases of 40 batteries = 2,720 individual batteries
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2340-2019 |
| Date reported | August 28, 2019 |
| Date initiated | September 25, 2018 |
| Recalling firm | Pro-Dex Inc |
| Firm location | Irvine, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2340-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pro-Dex Inc. Units affected: 68 cases of 40 batteries = 2,720 individual batteries.
Why was this product recalled? ▼
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2340-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2340-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 28, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.