KLS Martin Battery Pack — Class II medical device recall Z-0280-2025
Ongoing recall by Pro-Dex Inc, reported 2024-11-06, distributed in FL. The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings insid
| Recall number | Z-0280-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pro-Dex Inc, Irvine, CA, United States |
| Recall initiated | 2024-09-23 |
| Classified | 2024-10-31 |
| Reported by FDA | 2024-11-06 |
| Distributed | FL |
| Quantity | 2,000 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00856482008115, 00856482008122, 10856482008129 |
| Lot numbers | K0UB9, KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129, KLS-SD-2000/00856482008115KLS |
| Model numbers | 001, 040, BP2, KLS-SD-2000 |
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.
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-0280-2025. 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.