Medical device recalls, whether voluntary or mandated by the FDA, ensure patient safety. Ten medical supply recalls reported by Becker's Hospital Review since the beginning of October:
- 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.
- Getinge recalled 137 battery packs for its intra-aortic balloon pump after discovering some of the battery packs don't work properly and could cause the device to stop working.
- Zimmer Biomet recalled its ROSA One 3.1 Brain Application, a robotic platform that helps neurosurgeons position medical instruments during surgery, after finding a software error that could lead to incorrect placement of instruments during procedures.
- Aligned Medical Solutions recalled several lots of its convenience kits after finding they contained Cardinal Health's Monoject Flush prefilled saline syringe, which has been recalled due to the potential for the syringe's plunger to draw back and reintroduce air into the syringe.
- Cook Medical recalled all lots of its transseptal needles after receiving complaints of rust on some of the needles.
- Abbott recalled two of its Alinity COVID-19 test kits after finding they can yield false positive results.
- DeRoyal Industries recalled 2,856 procedure packs that contain an irrigation warming set that may leak aluminum.
- Medtronic recalled the remote control of certain insulin pumps because it is vulnerable to hackers.
- Imperative Care recalled its Zoom 71 reperfusion catheter, used to remove blood clots in the brain after a stroke, because of an increased risk of the device breaking during use.
- Coppertone recalled five types of its aerosol sunscreen after finding they contain benzene, a carcinogen.