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 20801–20820 of 38,428 recalls
Recalled Item: Optima CT 540
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CT Goldseal Optima CT 600
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution EVO 3.6
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MI Digital Ready
The Issue: DIGITAL ReadyCT/PET systems recently installed with a GE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery IQ 2.0 20cm
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima CT 520
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT 160 1.5D STD WAUK
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MI
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery RT labeled as: a. MID BJG
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CT Goldseal BrightSpeed 16 PWR TIO 2 YR
The Issue: Some CT and CT/PET systems recently installed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER
The Issue: During long-term storage (i.e. military depot), the interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Complete Knee System
The Issue: Two lots of tibial bearings were commingled. There
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius GS Premium Anesthesia Machine
The Issue: The Draeger anesthesia device may be able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK
The Issue: There is a potential for the patient port
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perseus A500 Anesthesia Machine
The Issue: The Draeger anesthesia device may be able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius GS Tiro Anesthesia Machine
The Issue: The Draeger anesthesia device may be able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius GS MRI Anesthesia Machine
The Issue: The Draeger anesthesia device may be able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK
The Issue: There is a potential for the patient port
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo Anesthesia Machine
The Issue: The Draeger anesthesia device may be able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK
The Issue: There is a potential for the patient port
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.