Small DKS Disposable Kerrison System — Class II medical device recall Z-0651-2025
Ongoing recall by Folsom Metal Products, Inc., reported 2024-12-18, distributed in KS, LA, MI, NY, TX. Units were not intended for commercial distribution and inadvertently distributed.
| Recall number | Z-0651-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Folsom Metal Products, Inc., Pelham, AL, United States |
| Recall initiated | 2023-10-30 |
| Classified | 2024-12-06 |
| Reported by FDA | 2024-12-18 |
| Distributed | KS, LA, MI, NY, TX |
| Quantity | 6 sets |
| Lot numbers | 1578 |
| Model numbers | 330.013, 330.014, DKS-63030 |
Product
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
Reason for recall
Units were not intended for commercial distribution and inadvertently distributed.
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-0651-2025. 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.