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 32741–32760 of 38,428 recalls
Recalled Item: ExacTrac is intended to be used to place patients at
The Issue: When using multiple isocenters (radiation treatment targets) within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MK5 NX Controller--Wheelchair controller
The Issue: M41 Powered Wheelchairs received through Invacare Service Parts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part
The Issue: Products were held at improper storage temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number:...
The Issue: Product was held at temperature above the labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part
The Issue: Products were held at improper storage temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number:
The Issue: Products were held at improper storage temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number:
The Issue: Products were held at improper storage temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML)
The Issue: Products were held at improper storage temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part
The Issue: Products were held at improper storage temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis EMPIRA NC RX PTCA Dilatation Catheter
The Issue: The balloon may exhibit resistance to the removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis EMPIRA RX PTCA Dilatation Catheter
The Issue: The balloon may exhibit resistance to the removal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Device Brand Name: Distal Radius Fracture Repair System Device Classification
The Issue: The firm received complaints indicating that the drill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS ADVIA Centaur CP Immunoassay System BNP kit
The Issue: Complaints of failed calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS ADVIA Centaur CP Immunoassay System BNP kit
The Issue: Complaints of failed calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT: product code 882482
The Issue: Flat Panel Display (FPD) failed to remain securely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in
The Issue: Test results may be erroneously elevated or report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable StrykeFlow Tip
The Issue: Internal review found that six lots of Disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LP
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Name: Pasteur Pipets
The Issue: Identification of packaging breach of the nylon pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 mL Reaction Vessels (a consumable of the Abbott m2000sp
The Issue: Abbott Molecular identified that some of the 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.