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 13561–13580 of 38,428 recalls
Recalled Item: Grace Medical *** COX BONE DUST COLLECTOR ***
The Issue: During internal Age Testing, holes were found in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grace Medical *** spineX BONE DUST COLLECTOR ***
The Issue: During internal Age Testing, holes were found in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grace Medical *** SHEEHY BONE DUST COLLECTOR ***
The Issue: During internal Age Testing, holes were found in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IOLMaster 700
The Issue: When using software 1.90.2.09 or 1.90.8.06 and using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: visby medical COVID-19 Test kit *** An in vitro diagnostic
The Issue: Two issues: 1) 5 Lots were found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Medela .0193 AXS Universal Aspiration Tubing (01)07612367053921 -
The Issue: Incorrect expiration date of "2023-07-24" on label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 60" (152 cm) Appx 1.9 ml
The Issue: Due to the incorrect filter assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM S-ICD Model A209
The Issue: Electrical overstress may lead to device malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM MRI S-ICD Model A219
The Issue: Electrical overstress may lead to device malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 154 cm (61 IN) APPX 1.5ml
The Issue: Due to the incorrect filter assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7 IN (18cm) APPX 0.43ml
The Issue: Due to the incorrect filter assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 60 IN (152cm) APPX 1.5 ml
The Issue: Due to the incorrect filter assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM S-ICD pulse generators
The Issue: Accelerated battery depletion may result in a need
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMBLEM MRI S-ICD pulse generators
The Issue: Accelerated battery depletion may result in a need
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer - In vitro diagnostic testing of
The Issue: Multiple issues in Software v1.23.2 and lower-may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH 930 Analyzer - In vitro diagnostic testing of
The Issue: Multiple issues in Software v1.23.2 and lower-may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer - In vitro diagnostic testing of
The Issue: Multiple issues in Software v1.23.2 and lower-may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box
The Issue: Purple ink located on the outside label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.