FDA Device recall Z-0650-2025
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Lar…
- FDA Device
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Lar… by Folsom Metal Products, citing units were not intended for commercial distribution and inadvertently distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0650-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-30 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Folsom Metal Products |
| Distribution | KS, LA, MI, NY, TX |
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)
Reason
Units were not intended for commercial distribution and inadvertently distributed.
Identifiers
| code_info | Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0650-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.