# FDA recall Z-0280-2025

> **Pro-Dex Inc** · Class II · device recall initiated 2024-09-23.

## Product

KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000

## Reason for recall

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

## Distribution

US distribution to FL only.

## Key facts

- **Recall number:** Z-0280-2025
- **Recalling firm:** Pro-Dex Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-23
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0280-2025

## Citation

> AI Analytics. FDA recall Z-0280-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0280-2025. Source: US FDA. Licensed CC0.

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