🏥 Medical Devices • 4,262 recalls
Medtronic MiniMed
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
Medtronic MiniMed
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
Medtronic MiniMed
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
Medtronic MiniMed
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
Medtronic MiniMed
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Medtronic MiniMed
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
Menarini Silicon Biosystems
High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Alcon Laboratories Ireland
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Tandem Diabetes Care
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
GE Healthcare
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Ion Beam Applications S.A.
First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
XVIVO PERFUSION AB
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Busse Hospital Disposables
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products