Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety.
Here are the 10 largest medical supply recalls of 2021, starting with the most recent:
1. Ellume recalled more than 2 million of its at-home COVID-19 tests after a higher-than-acceptable number of false positive results were reported to the FDA, the company said Nov. 10.
2. Armstrong Medical Ltd. recalled about 214,000 of its Amsorb Plus prefilled cans Sept. 23, which contain a chemical substance used in anesthesia machines to absorb carbon dioxide the patient breathes out while under anesthesia.
3. Smiths Medical recalled around 520,000 of its Normoflo irrigation fluid warmers and Normoflo irrigation warming sets on Sept. 15, which are used for warming blood, blood products and intravenous solutions before use, because of the potential for aluminum ions leaching into the fluids.
4. Cardinal Health recalled about 267 million prefilled syringes Aug. 19 after finding the plunger may pull back and reintroduce air into the syringe, which could cause serious adverse outcomes.
5. Philips Respironics recalled around 204,000 ventilators and BiPAP machines July 22 due to potential health risks from sound abatement foam.
6. Smiths Medical recalled around 1.4 million insulin syringes June 25 after discovering some had skewed measurement markings.
7. Philips recalled about 3.5 million ventilation devices June 14 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.
8. Lepu Medical Technology recalled about 8.4 million antibody tests and 205,000 antigen tests May 28 after finding they were likely to produce false results. The tests weren't authorized, cleared or approved for marketing or distribution in the U.S.
9. CareFusion 303 recalled around 145,000 BD Alaris Pump Module Model 8100s due to risk of stuck or unresponsive keys on April 16.
10. Medtronic recalled around 239,000 of its Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators and cardiac resynchronization therapy devices on April 12.