Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are eight that have been reported to the FDA since mid-October:
- 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 during use.
- 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 back into the syringe.
- Merck recalled about 22,000 vials of its Cubicin antibiotic after receiving a customer complaint of glass in a vial.
- Lupin Pharmaceuticals recalled several batches of hypertension pills after an analysis found that some batches contained levels of a possible carcinogen higher than the FDA's acceptable limits.
- Cook Medical recalled all lots of its transseptal needles after receiving complaints of rust on some of the needles.
- Bryant Ranch Prepack recalled a lot of methocarbamol pills after finding the bottles were labeled as containing 500 mg pills but actually contained 750 mg pills.
- Abbott recalled two of its Alinity COVID-19 test kits after finding they can yield false positive results.