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 36141–36160 of 38,428 recalls
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5
The Issue: Siemen's issued a Customer Information Letter under Update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20-Pole Eco Cable
The Issue: Biosense is recalling the 20-Pole Eco Cable because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo.plaza SW version VA20 with Mammography license. image processing
The Issue: Siemens issued a Customer Safety Notice to inform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quick Connect QLC1677E
The Issue: During a routine label review, the firm identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm
The Issue: In March 2013, Medtronic issued a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 16 Multi-Slice CT Scanner System
The Issue: User error of the NeuViz 16 or NeuViz
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz Dual series CT Scanner System
The Issue: User error of the NeuViz 16 or NeuViz
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse...
The Issue: The product specifications sheet, part of the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sepp
The Issue: An internal review of CareFusion's labeling for preoperative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control
The Issue: American Medical Systems, Inc. is initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control
The Issue: American Medical Systems, Inc. is initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diacap(R) Ultra Dialysis Fluid Filter
The Issue: There is the potential of the residual moisture
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir
The Issue: Certain lots of Reagent reservoirs, may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse...
The Issue: An internal protective fuse can be unintentionally activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Mammomat Inspiration - full-field digital mammography Product Usage:...
The Issue: Firm became aware of an unintended behavior when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allen Traction Boot
The Issue: Some units may have been assembled incorrectly which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PCA 3 infusion pump allows clinicians
The Issue: The infusion pump has a clear plastic door
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The LifeCare PCA infusion system with Hospira MedNet software allows clinicians
The Issue: The infusion pump has a clear plastic door
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDI Blood Parameter Monitoring System 500 with Arterial blood parameter
The Issue: Terumo discovered through its own testing that CDI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.