FDA Medical devices recall ·
DKS Disposable Kerrison System recall
- Recall number
- Z-0650-2025
- Date
- (initiated October 30, 2023)
- Company / brand
- Folsom Metal Products, Inc.
1449 Court Pl, Pelham, AL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 42 sets
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Units were not intended for commercial distribution and inadvertently distributed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.
Distribution
US distribution to KS, LA, MI, NY, TX.
States: Kansas Louisiana Michigan New York Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0650-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.