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 31001–31020 of 38,428 recalls
Recalled Item: ThermoFlo 1 HME
The Issue: Outer shipping carton was marked with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO C and AMSCO 400 Steam Sterilizers
The Issue: STERIS has identified that the control board software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Q-Syte Luer Access Split Septum
The Issue: Becton Dickinson received an elevated number of complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carton: Richard-Allan Scientific CYTO-STAIN
The Issue: The case was correctly labeled as REF 7501R,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Spirit TM Select bed is a Med-Surg bed intended
The Issue: It was identified that in some situations the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to
The Issue: Possibly incomplete archived studies during pre-fetch. In a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Velocity" Biopsy Valve
The Issue: The company has received reports of structural non
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EOS
The Issue: When performing calibration, an alert message on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Swivel Connector with Suction Port Connector
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transonic Hemodialysis Monitor
The Issue: Customer unable to obtain measurements due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thumb Screw for the Synthes Recon Locking Aiming Arm for
The Issue: For certain lots, the incorrect raw material of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Variable Angle Locking Peg
The Issue: Locking pegs were not locking during distal radius
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac versions 6.x patient positioning systems are used to position
The Issue: The ExacTrac 6.x Patient Positioning System may incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: safety issue due to improper assembly associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vacuum Source Tubing Set for the EndoWrist Stabilizer for da
The Issue: There is the possibility that the Vacuum Source
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder
The Issue: Incorrectly packaged. Outer and inner labeling may incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intraocular Lens (IOL)
The Issue: Aaren Scientific is recalling intraocular lenses because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60
The Issue: The firm is recalling sterile enteral feeding syringes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115)
The Issue: Devices were not sterilized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging
The Issue: Devices were not sterilized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.