Adept Medical Ltd has recalled 35,920 ear ventilation tubes, including various T-Tube and Donaldson silicone models. These surgical devices were distributed in the United States without the required FDA 510(k) clearance, which means the agency has not reviewed the manufacturer's data to ensure the products are safe and effective for their intended use. No incidents or injuries have been reported to date regarding this issue.
Using a medical device that has not been cleared by the FDA poses a potential safety risk because the product's performance and manufacturing standards have not been verified. This lack of regulatory oversight could lead to complications or unexpected failure of the tube once implanted during ear surgery.
13,070 total units (9,090 US, 3,980 OUS)
2,010 units (630 US, 1,380 OUS)
2,610 units (240 US, 2,370 OUS)
6,280 units (2,500 US, 3,780 OUS)
5,120 units (2,190 US, 2,930 OUS)
310 units (160 US, 150 OUS)
2,440 units (1,940 US, 500 OUS)
4,080 units (1,510 US, 2,570 OUS)
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.