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 7381–7400 of 38,428 recalls
Recalled Item: DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert
The Issue: Orthopedic device components were not subjected to final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DJO Surgical: Altivate Reverse
The Issue: Orthopedic device components were not subjected to final
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HUDSON RCI Addipak
The Issue: Product dispositioned for scrap for sterility failure investigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only
The Issue: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible...
The Issue: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10...
The Issue: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible...
The Issue: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves
The Issue: Some surgical glove sterile pouches were not completely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3T Heater Cooler System
The Issue: The firm's labeling (Quick Reference Guide) contains incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GAMMEX NON-LATEX PI GREEN Surgical gloves
The Issue: Some surgical glove sterile pouches were not completely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE STERILE IRIS SCISSORS CVD/STD
The Issue: 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Assayed Chemistry Control Premium Plus Level 3
The Issue: there has been a transcription error in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Upper roller bracket (part number 1088370) for the Gen2 gantry
The Issue: It is possible the upper roller bracket in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT
The Issue: Philips has identified three software issues with compliance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SynCardia 50cc TAH-t
The Issue: Artificial hearts contain a epoxy resin that has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with
The Issue: Avanos has received an increase in complaints from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GS70H Salus Surgical Table
The Issue: When the control of the operating table was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GS70 Salus Surgical Table
The Issue: When the control of the operating table was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perifix¿ / Epidural anesthesia set
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magnifuse Bone Graft
The Issue: The incorrect product labeling was applied to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.