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 31781–31800 of 38,428 recalls
Recalled Item: ROSA Surgical Device 2.5.8
The Issue: failure of a force feedback sensor that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Small Electric Drive (SED)
The Issue: The device may operate solely in reverse mode,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic
The Issue: Illumina has confirmed a software limitation with MiSeq
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS CHEMISTRY PRODUCTS TRIG Slides
The Issue: for biased results using the specific lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ascension Orthopedics PyroSphere CMC & PyroSphere TMT
The Issue: Integra LifeSciences has determined that a portion of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate...
The Issue: AMO has received complaints where the finger grip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINI PEDIATRIC Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONMED PEDIATRIC R2 Multifunction Electrodes
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PEDIATRIC Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADULT Radiotransparent Electrode
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONMED ADULT R2 Multifunction Electrodes
The Issue: Philips Healthcare made changes to the design of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and
The Issue: Breakage of the nut that secures the heater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9
The Issue: An INCORRECT item number is packed within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating
The Issue: Maquet has confirmed through a customer complaint that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500
The Issue: Customer complaints of discrepant flagged and/or un-flagged patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Additional devices identified in new FSN MA-FCO 83000190: QLAB versions
The Issue: When using the QLAB Auto 2D Quantification (a2DQ)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.