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 2881–2900 of 38,428 recalls
Recalled Item: Dexcom G6
The Issue: Under very rare situations, the Dexcom G6 touchscreen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G6
The Issue: Under very rare situations, the Dexcom G6 touchscreen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G6
The Issue: Under very rare situations, the Dexcom G6 touchscreen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid
The Issue: Devices were distributed in the U.S. market without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniDock Product Name: Integrated Nucleic Acid Testing Device
The Issue: Devices were distributed in the U.S. market without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Lumenis Pulse 120H 30 amp
The Issue: The initial current in certain chargers may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Pump Module The BD Alaris System
The Issue: Due to User Manual/Direction for Use incorrectly instructing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedFlex 2.0 Bio-ID Spare Parts REF
The Issue: Due to fingerprint scanner failing resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate
The Issue: Complaints of the locking screw passing through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.