KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling… — Class II medical device recall Z-1391-2023
Ongoing recall by Pro-Dex Inc, reported 2023-04-26, distributed nationwide. Incorrect Unique Device Identifier/GTIN code was used on product.
| Recall number | Z-1391-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pro-Dex Inc, Irvine, CA, United States |
| Recall initiated | 2023-02-14 |
| Classified | 2023-04-14 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 199 devices |
| Lot numbers | K0C1B, K0D3P, K0E8T, K0FSD, K0HGV |
| Model numbers | A9671, PDEC-1000-2 |
Product
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
Reason for recall
Incorrect Unique Device Identifier/GTIN code was used on product.
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-1391-2023. 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.