- 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.
