Class II — Folsom Metal Products, Inc.
| Recalling firm | Folsom Metal Products |
|---|---|
| Registered facility | FOLSOM METAL PRODUCTS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Units were not intended for commercial distribution and inadvertently distributed. |
| Product | DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016) |
| Quantity | 42 sets |
| Distribution | US distribution to KS, LA, MI, NY, TX. |
| Initiated | 2023-10-30 |
| Classified | 2024-12-06 |
| Recall number | Z-0650-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Folsom Metal Products, Inc. (Z-0650-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95476/
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