Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety.
Here are five reported since Feb. 4:
1. E25Bio recalled over 73,000 COVID-19 direct antigen rapid tests due to them being marketed and distributed to U.S. customers without authorization, clearance or approval from the FDA. Labeling distributed with some tests also includes inaccurate claims and instructions. There have been no reports of injuries, adverse health consequences or death, according to the FDA.
2. BASE10 Genetics recalled over 455,000 RNAstill MTM specimen collection kits on Feb. 18 due to distribution without proper premarket clearance from the FDA. There have been no reports of injuries, adverse health consequences or death, according to the FDA.
3. Vyaire Medical recalled around 2,605 Bellavista 1000 and 1000e series ventilators on Feb. 17 due to software configuration issues causing the machines to fail to ventilate and generating a technical failure alarm. There have been 18 complaints and seven injuries, but no reports of death, according to the FDA.
4. Family Dollar recalled products shipped to 404 stores after a rodent infestation was discovered in a West Memphis, Ark.-based distribution center.
5. Illegally imported at-home COVID-19 test kits from SD Biosensor, a South Korean diagnostics company, were recalled in the U.S. on Feb. 4, according to a recall notice from the FDA.