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 19701–19720 of 38,428 recalls
Recalled Item: GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma
The Issue: A detector can detach and fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack
The Issue: to lead to a false negative results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH...
The Issue: A detector can detach and fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek
The Issue: The pouches of certain lots of product may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Camera Arm Drape (Box of 20) individually sealed in poly-Tyvek
The Issue: The pouches of certain lots of product may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Accessory Kit
The Issue: The pouches of certain lots of product may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Accessory Kit
The Issue: The pouches of certain lots of product may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott i-STAT CG8+ Cartridges intended for use in the in
The Issue: Inaccurate potassium results may be generated. When testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock
The Issue: There is potential to break during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips
The Issue: Abnormally high INR test results with the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System
The Issue: The service manual was not updated at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A
The Issue: ability to leak once used for compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A
The Issue: ability to leak once used for compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A
The Issue: ability to leak once used for compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A
The Issue: ability to leak once used for compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX Empty EVA Bags - 500 mL - Product Usage:
The Issue: ability to leak once used for compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0mm Headless Compression Screw
The Issue: The product inside the package does not match
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tritanium TL Steerable Inserter
The Issue: The firm received complaints related to the locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.