Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are five reported to the FDA since the end of May:
- Philips recalls 3.5M ventilation devices, cites potential cancer risk
Philips has recalled roughly 3.5 million ventilation devices after finding a defect that could cause cancer. The ventilators use polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects. - Viona Pharmaceuticals recalls metformin due to carcinogen
Viona Pharmaceuticals, a generic drugmaker in Cranford, N.J., has recalled two lots of metformin tablets after finding they contain levels of Nitrosodimethylamine, or NDMA, above acceptable daily limits. - Innova Medical Group recalls unauthorized COVID-19 test
Innova Medical Group has recalled at least 77,339 of its COVID-19 antigen tests after the FDA discovered the company was selling the test without its approval and that it carries the risk of false positive and false negative results. - Lepu Medical Technology recalls COVID-19 antigen test
Lepu Medical Technology has recalled its COVID-19 rapid antigen test after finding it's likely to produce false results. The test wasn't authorized, cleared or approved for marketing or distribution in the U.S. - Step-Har Medical recalls infusion pump
Step-Har Medical, a biomedical repair company in Fountain Valley, Calif., has recalled the Alaris infusion pump after finding a component of the device may crack or separate, leading to an inaccurate delivery of fluids to patients. The pump is used to deliver medications, nutrients, blood and other therapies into a person's body in controlled amounts.