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 7561–7580 of 38,428 recalls
Recalled Item: IMPIX 3D
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX TLIF
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PASS LP
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPIX ALIF S/A
The Issue: There is a potential for a product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Libre 2 Readers
The Issue: If blood glucose monitoring system users attempt to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD HORIZON Spinal System Solera Awl Tip Tap
The Issue: Incorrect Laser Marking - Solera Awl Tip Tap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The following Pro.specta Emission Computed Tomography Systems that were...
The Issue: During a whole-body planar scan with auto-contour, there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM S-ICD Pulse Generator Model A209
The Issue: There is a potential for a rare interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM MRI S-ICD Pulse Generator Model A219
The Issue: There is a potential for a rare interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the...
The Issue: for reagent carryover on the Atellica CH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the
The Issue: for reagent carryover on the Atellica CH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the
The Issue: for reagent carryover on the Atellica CH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SurgiCount+ Software Application-indicated as an adjunctive technology for...
The Issue: for current software to miscount when scanning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH LDL Cholesterol- In vitro diagnostic use in the
The Issue: for reagent carryover on the Atellica CH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Five S 5 3x65
The Issue: Flexible intubation endoscopes sterility assurance can not be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASG-001
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 50-GEL20
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedural kits containing ultrasonic transmission gel
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedural kits containing ultrasonic transmission gel
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Procedural kits containing ultrasonic transmission gel
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.