Battery Pack KLS-SD-1000 Case — Class II medical device recall Z-1094-2016
Terminated recall by Pro-Dex Inc, reported 2016-03-23, distributed in FL. The sterile battery may contain particulates within the sterile package.
| Recall number | Z-1094-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pro-Dex Inc, Irvine, CA, United States |
| Recall initiated | 2015-12-23 |
| Classified | 2016-03-11 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-07-21 |
| Distributed | FL |
| Quantity | 1,995 total |
| Reason classes | sterility, specification failure |
| Lot numbers | 509567, K055R |
| Model numbers | KLS-BP-040 |
Product
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
Reason for recall
The sterile battery may contain particulates within 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-1094-2016. 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.