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 8441–8460 of 38,428 recalls
Recalled Item: Presource Kit
The Issue: Inadvertently released for distibution without sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient
The Issue: There is a low possibility that an electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Attest Steam Chemical Integrators
The Issue: 3M Attest Steam Chemical Integrators with dates of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher Wallace Stimulator Models FW-100 and FW-200
The Issue: If the batteries are installed incorrectly, the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ET III Nano-HA fixture System ET NH Dental Implant Model
The Issue: Mis-labeled length of the dental implant on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Attest Steam Chemical Integrators
The Issue: 3M Attest Steam Chemical Integrators with dates of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES (Med ES Main)
The Issue: Due to an automated dispensing cabinet software issue,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiSeq Dx Instrument
The Issue: Cybersecurity vulnerability concerning the software used for sequencing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KARL STORZ Radel Sterilization Trays
The Issue: Plastic sterilization trays used to encase and protect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NextSeq 550Dx Instrument
The Issue: Cybersecurity vulnerability concerning the software used for sequencing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHDOG Hemostasis Valve Kit
The Issue: The firm received complaints of the Insertion Tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology...
The Issue: Reassignment of the Atellica CH Toxicology Calibrators (TOX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the
The Issue: Reassignment of the Atellica CH Toxicology Calibrators (TOX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxU 840m Iris Urine Microscopy Analyzer
The Issue: Beckman Coulter has become aware of an intermittent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHDOG ACCESSORY KIT (20-PACK)
The Issue: The firm received complaints of the Insertion Tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select
The Issue: Beckman Coulter has become aware of an intermittent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuraLife Autoclavable Double Swivel Elbow
The Issue: DuraLife devices instructions for cleaning and sterilization have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UA WIN 10 Kit
The Issue: Beckman Coulter has become aware of an intermittent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Bicarbonate
The Issue: There is a potential for a decrease in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Bicarbonate
The Issue: There is a potential for a decrease in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.