Folsom Metal Products, Inc. is recalling approximately 48 DKS Disposable Kerrison System instrument sets because they were accidentally distributed to customers when they were not intended for commercial sale. The affected surgical kits come in two sizes (3.75mm and 6.35mm) and contain instruments such as trocars, lighted cannulas, and Kerrison tools. Because these units were distributed inadvertently, some may not have undergone proper sterilization or validation processes, making them unsafe for use in surgical procedures.
The instruments were not intended for commercial distribution and may not have been properly sterilized. Using non-sterile or unvalidated surgical instruments can lead to serious patient infections or surgical complications. No injuries have been reported to date.
Instrument sets containing Large Obturator Trocar, Large Lighted Cannula, Large Kerrison, Small Obturator Trocar, Small Lighted Cannula, and Small Kerrison. Includes 4 units that were not assigned lot numbers because they were not sent to sterilization.
Instrument sets containing Small Obturator Trocar, Small Lighted Cannula, and Small Kerrison.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.