Healthmark Industries Co., Inc. is recalling 4,291,797 Mesh Style Tip Protectors because the products do not have required FDA clearance. These devices are intended to protect the tips of medical instruments during sterilization and handling. No incidents or injuries have been reported, but because they lack regulatory clearance, the FDA has not reviewed their safety or effectiveness.
The lack of FDA clearance means the devices have not been validated for their intended use in medical settings, which could potentially impact the sterilization or protection of surgical instruments.
No UDI. All lots affected.
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.