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 38061–38080 of 38,428 recalls
Recalled Item: 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution
The Issue: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system
The Issue: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R-20J
The Issue: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system
The Issue: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R-30H
The Issue: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm)
The Issue: The tip of the product could come loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: As part of GE Innova IQ table introduction,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a
The Issue: Linear performance information in product insert does not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADstream software Product Usage: CADstream is an image processing system
The Issue: Customers may experience an issue with the software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Practix Convenio Mobile X-ray system Worldwide...
The Issue: When the system is switched off or when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgical System IS3000 with the da Vinci
The Issue: Improper restraints during transportation of the da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5
The Issue: Exactech, Inc. of Gainesville, FL recalled their Optetrak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoftLab with SA INST versions: 3.1.6.12
The Issue: On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thyroidectomy Indication for the da Vinci Surgical Systems
The Issue: Promotional literature for use of the da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxI 600 Access Immunoassay Systems
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxI 800 Access Immunoassay Systems
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 660i
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Total T3 Reagent
The Issue: A recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Mozaik Strip 10 cc Product Usage: The product is
The Issue: The Instructions for Use {IFU} {Putty Part Number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Mozaik Putty 2.5cc
The Issue: The Instructions for Use {HIFU} {Putty Part Number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.