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 28921–28940 of 38,428 recalls
Recalled Item: CT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011 Post-Operative...
The Issue: Knee brace could fail to maintain the locked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative...
The Issue: Knee brace could fail to maintain the locked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075...
The Issue: Knee brace could fail to maintain the locked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris EtCO2 Module
The Issue: CareFusion is recalling the Alaris EtCO2 module model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Temple Thermometer labeled under: Bestmed
The Issue: An incorrect calibration of the thermometer that causes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perseus A500 Anesthesia Workstation
The Issue: There is a potential problem with the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended
The Issue: The Nebulizer mask malfunctions in that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care CKMB DilPak- an in vitro diagnostic product
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.
The Issue: During an internal testing, Natus Medical Incorporated, identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care pBNP TestPak- in vitro diagnostic test for
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care CKMB TestPak- in vitro diagnostic test for
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the
The Issue: Stratus CS Cartridge Barcode labels may not scan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare DigitalDiagnost stationary X-ray system
The Issue: The detector may signal that it is ready
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.