CLASS II ONGOING Device recall · Reported 18 Dec 2024 · FDA Enforcement Report
Small DKS Disposable Kerrison System recalled by Folsom Metal Products
Folsom Metal Products is recalling Small DKS Disposable Kerrison System, distributed in Kansas, Louisiana, Michigan, New York, Texas. The recall was initiated on 30 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0651-2025
- FDA event ID
- 95476
- Recalling firm
- Folsom Metal Products, Pelham, AL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2023
- FDA classified
- 6 Dec 2024
- Reported
- 18 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Oct 2023 | Recall initiated by company | |
| 6 Dec 2024 | Classified by FDA | +403 days |
| 18 Dec 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Units were not intended for commercial distribution and inadvertently distributed.
Product as listed by the FDA
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)
Where it was distributed
US distribution to KS, LA, MI, NY, TX.
Questions about this recall
Why was it recalled?
Units were not intended for commercial distribution and inadvertently distributed.
Which lots are affected?
Catalog Number DKS-63030, Lot Number: 1578.
Where was it sold?
US distribution to KS, LA, MI, NY, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95476This product is part of a recall event; the main page for the event is DKS Disposable Kerrison System recalled by Folsom Metal Products.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DKS Disposable Kerrison System recalled by Folsom Metal Products | Folsom Metal Products | Other | 5 states |
More recalls from Folsom Metal Products
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
| Device | CLASS II | Frontier Devices recalled by Folsom Metal Products | Folsom Metal Products | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |