Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 34961–34980 of 38,428 recalls
Recalled Item: CATH ANGIOGRAPHY DRAPE PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIO PACK #2
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANGIOGRAPHY PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATH LAB CUSTOM PACK
The Issue: Guidewire .035x150 3MMJ TCFC, item number 88241, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Fabius GS Premium
The Issue: During final testing of the Draeger Fabius GS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens EasyLink Informatics System V4.0/V5 Siemens
The Issue: May not perform as intended under certain conditions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Application Instrument Sternal Zip Flex System intended for use
The Issue: When using the 1st generation Zip Fix Application
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Programmable Pump
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Kit
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Programmable Pump
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Kit
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Programmable Pump
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Kit (1 unit)
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Kit (6 units)
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedStream Programmable Pump
The Issue: Drug flow rates exceeding programmed flow rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products
The Issue: Following the identification of the disassociation of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cypher MIS Screw System
The Issue: Several complaints were reported to exhibit screw head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal (R) Surgical Eye Spears
The Issue: One lot of eye spears was labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for
The Issue: Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.