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 28641–28660 of 38,428 recalls
Recalled Item: MicroScan Pos Breakpoint Combo Panel Type 20
The Issue: Beckman Coulter has confirmed falsely negative results for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Pos Combo Panel Type 33
The Issue: Beckman Coulter has confirmed falsely negative results for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Pos Combo Panel Type 21
The Issue: Beckman Coulter has confirmed falsely negative results for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Pos Breakpoint Combo Panel Type 23
The Issue: Beckman Coulter has confirmed falsely negative results for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Pos Combo Panel Type 34
The Issue: Beckman Coulter has confirmed falsely negative results for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optional PS500 Power Supply Unit for the Evita V500 Ventilator
The Issue: The firm became aware of cases in which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 600 Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the DxH 800 Slidemaker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 600 Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the DxH 800 Slidemaker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the DxH 800 Slidemaker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is
The Issue: Contamination of product with possible Bacillus spp
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BladderScan BVI 9600
The Issue: The firm is providing customers with an updated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Columbus Revision Knee System
The Issue: Aesculap Inc. US has initiated a recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medrad Source Administration Sets
The Issue: The firm's investigation of the Medrad Intego indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter INTERLINK System
The Issue: for dark loose particulate matter (400 microns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter CLEARLINK System
The Issue: for dark loose particulate matter (400 microns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Y-Type Spike Adapter
The Issue: for dark loose particulate matter (400 microns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope AVL Video Laryngoscope (AVL)
The Issue: Certain models and serial numbers of GlideScope GVL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Video Laryngoscope (GVL)
The Issue: Certain models and serial numbers of GlideScope GVL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bond Polymer Red Detection DS9390 kits. The common name
The Issue: The Firm informed the importer/distributor, Leica Microsystems, a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Certain Gingihue TM 15 degree Angled Post Dental implants
The Issue: Pouches may not have been sealed during packing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.