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 17441–17460 of 38,428 recalls
Recalled Item: Go-EZ Screw 6.5x115
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x85
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x90
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Single Trocar 1.1x150mm
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x110
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3/8" FloPump
The Issue: The firm has become aware that they have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOSEBLEED TRAY Kit Code: MNS3885
The Issue: Various medical device kits contain MAJOR Nasal Decongestant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPISTAXIS TRAY Kit Code: MNS10165
The Issue: Various medical device kits contain MAJOR Nasal Decongestant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YNHH SCOPE KIT Kit Code: MNS10475
The Issue: Various medical device kits contain MAJOR Nasal Decongestant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vigilant Agilia
The Issue: The firm is correcting four software anomalies and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLUMAT MC AGILIA US
The Issue: The firm is correcting four software anomalies and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 Model # 728231
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core128 Model # 728323
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iCT
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT Model # 882456
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iCT SP Model # 728311
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Model # 728321
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vereos PET/CT Model # 882446
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IQon Spectral CT Model # 728332
The Issue: In certain instances when performing a cardiac step
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.