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 381–400 of 38,428 recalls
Recalled Item: PALACOS Product Name: PALACOS R pro 40
The Issue: increase of complaints regarding the breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PALACOS Product Name: PALACOS MV+G pro 40
The Issue: increase of complaints regarding the breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LDL-Cholesterol assay is comprised of two distinct phases. In
The Issue: Beckman Coulter identified that LDL Cholesterol OSR6x96 is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion Systems R3.0. Includes the following label descriptions and
The Issue: Nine (9) identified software issues which may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog
The Issue: Torque screw may crack or separate. If used,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial 900 MHz Call Station
The Issue: Securitas Healthcare has become aware of a firmware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial 900 MHz Call Station
The Issue: Securitas Healthcare has become aware of a firmware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number:
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revogene C. difficile
The Issue: The affected lots show a decline in performance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMINOS Lotus Max
The Issue: A potential issue associated with LUMINOS Lotus Max
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
The Issue: Manufacturing deviation in which the ferrites specified for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allwell Inflation Device
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Numbers:...
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allwell Angioplasty Pack /B
The Issue: Inflation device handle may detach from the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ion Endoluminal System Product Name: Ion Vision Probe
The Issue: Due to probe bags that may have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Detachable 10in Pend FRU-1 Pend component for the AIRO Computed
The Issue: AIRO pendant replacement kits and upgrade do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.