Pro-Dex Surgical Driver Battery Packs Recalled for Visual Particulates
Pro-Dex Inc is recalling sterile surgical driver battery packs due to visual particulates found within the Tyvek pouches.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves visual particulates in a sterile medical device. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pro-Dex Inc is recalling the PRO-DEX Surgical Driver Battery Pack PDBP-001 Series, specifically the PDBP-040-2 model. The recall involves 68 cases of 40 batteries, totaling 2,720 individual batteries. These single-use, non-rechargeable sterile lithium ion batteries are accessories designed to power the PDSD-5000 surgical driver, which is used to drive surgical screws into bone in the cranio-maxillo-facial (CMF) region of the body.
The recall was initiated because visual particulates were found within the battery Tyvek pouches. The batteries are provided sterile for use with surgical drivers, and the presence of particulates compromises the sterile integrity of the product.
The affected products were distributed worldwide, including in the United States (California, Florida, Michigan, and Texas) and Finland. The specific lot numbers involved are K098N (contract packager lot 61900) and K0B3F (contract packager lot 62625). Healthcare providers and consumers should stop using these battery packs and contact Pro-Dex Inc for further instructions.
The recalled product
- 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…
- Manufacturer
- Pro-Dex Inc
Distribution
Related recalls
Same manufacturer · Pro-Dex Inc
See all →- HighSurgical Screwdriver Battery Pack Recalled for Foreign Material Contamination
FDA (Devices) · 2024-11-06
- ModerateKLS Martin Battery Packs Recalled for Switched Expiration Date Labels
FDA (Devices) · 2023-07-12
- ModerateKLS E-Coupling Adapter Recalled for Incorrect Product Identifier Code
FDA (Devices) · 2023-04-26
- ModeratePro-Dex Recalls Battery Packs for Surgical Screwdriver Due to Particulates
FDA (Devices) · 2016-03-23
- HighPro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers
FDA (Devices) · 2016-03-23
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- ModeratePro-Dex Recalls Battery Packs for Surgical Screwdriver Due to Particulates
FDA (Devices) · 2016-03-23
- HighPro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers
FDA (Devices) · 2016-03-23
- HighSurgical Screwdriver Battery Pack Recalled for Foreign Material Contamination
FDA (Devices) · 2024-11-06
- HighRAPIDSORB IPS Battery Pack recalled due to unconfirmed sterility
FDA (Devices) · 2024-03-13
- HighSurgical laser probes recalled over voids in sterile pouch seals
FDA (Devices) · 2026-02-11
- HighDIXI Medical Depth Electrodes recalled for potential sterile packaging defect
FDA (Devices) · 2022-02-09