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 961–980 of 38,428 recalls
Recalled Item: or BS737162 Automated Digital Cell Morphology analyzer DI-60
The Issue: Automated cell-locating device barcode reader may read the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON
The Issue: Affected catheters were reprocessed beyond validated cycles. This
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON
The Issue: Affected catheters were reprocessed beyond validated cycles. This
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lithotriptor
The Issue: The device may either fail to start up,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Meridian Bioscience
The Issue: The cap on the reaction buffer tube may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Meridian Bioscience
The Issue: The cap on the reaction buffer tube may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SimplyGo Mini
The Issue: Certain serial numbers of the SimplyGo Mini standard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GM85 Digital Mobile X-ray imaging System
The Issue: The four (4) M5 bolts that secure the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Good Neighbor Pharmacy
The Issue: Manufacturing defect causing LCD display issues with missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials
The Issue: A labeling error was identified on the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Panel 3 Specific Allergen
The Issue: The barcode orientation on affected devices causes incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medical Technology
The Issue: The nasal feeding tube may be occluded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eterna SCS IPG (Implantable Pulse Generator)
The Issue: There is a potential issue affecting Eterna Spinal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liberta RC DBS IPG (Implantable Pulse Generator)
The Issue: There is a potential issue affecting Eterna Spinal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medical Technology
The Issue: The nasal feeding tube may be occluded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medical Technology
The Issue: The nasal feeding tube may be occluded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Single Use Single Use Electrosurgical Snare SD-400
The Issue: Sterility compromised from small holes that may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Applied Medical Technology
The Issue: The nasal feeding tube may be occluded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3gAllergy Specific IgE Universal Kit
The Issue: The barcode orientation on affected devices causes incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Oak Mix Specific Allergen
The Issue: The barcode orientation on affected devices causes incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.