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 13901–13920 of 38,428 recalls
Recalled Item: Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23
The Issue: for Transcatheter Aortic Valve (TAV) leaflet damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in
The Issue: The firm has become aware of nine reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for
The Issue: Product shelf cartons incorrectly labeled as products intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROCEED Surgical Mesh Hernia Mesh Oval
The Issue: The firm is recalling the PROCEED Surgical Mesh
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Box Label: ION Fully Articulating Catheter
The Issue: The distal tip ring of the fully articulating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan Pump - Product Usage: indicated for male patients suffering
The Issue: increased occurrence of pump fracture over the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mako Integrated Cutting System (MICS) Handpiece
The Issue: Stryker has discovered a characterization issue associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Core Wire Guide
The Issue: Affected product was dropped during manufacturing, which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee floor
The Issue: Some electronic components within the generator were equipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alpen Clinic 100 Carbide Instruments (R100057C)
The Issue: The FG 557 bur was incorrectly packaged as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewRay MRIdian System: Model No. 10000
The Issue: There is a potential that components of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewRay MRIdian Linac System: Model No. 20000
The Issue: There is a potential that components of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CEI Cutting Edge Instruments (PTC-57C)
The Issue: The FG 557 bur was incorrectly packaged as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FG 57 100057X (100057X)
The Issue: The FG 557 bur was incorrectly packaged as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clinic Pack 100 Pieces FG 57 100057C (100057C)
The Issue: The FG 557 bur was incorrectly packaged as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Strauss 25 Carbide Dental Burs (100057XXV)
The Issue: The FG 557 bur was incorrectly packaged as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone
The Issue: Difficult to expel Geistlich Bio-Oss granules from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250i
The Issue: Treatment beam information disappears on Treatment Console screen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone
The Issue: Difficult to expel Geistlich Bio-Oss granules from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone
The Issue: Difficult to expel Geistlich Bio-Oss granules from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.