FDA Medical devices recall ·
KLS Martin Battery Pack recall
- Recall number
- Z-0280-2025
- Date
- (initiated September 23, 2024)
- Company / brand
- Pro-Dex Inc
2361 McGaw Ave, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2000
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Distribution
US distribution to FL only.
States: Florida
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0280-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.