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 10181–10200 of 38,428 recalls
Recalled Item: NuVasive MD Pulse III Multimodality System Pulse Software
The Issue: Due to an incorrect security key, customers were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Hydrophilic Wire Guide PART NUMBER (RPN): RFSPC-35-180
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWAS-35-150
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Hydrophilic Wire Guide PART NUMBER (RPN):RLPC-35-180 ORDER
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Hydrophilic Wire Guide PART NUMBER (RPN): RPC-35-180
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWS-35-80
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWS-35-150
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWA-18-150
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Hydrophilic Wire Guide PART NUMBER (RPN)RFPC-35-180 ORDER
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPW-35-150
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWA-35-150
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWA-18-80
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWAS-35-80
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner UniGlide Hydrophilic Wire Guide PART NUMBER (RPN): HPWA-35-80
The Issue: Product did not meet the acceptance criteria for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System with Version 3.7.2 and below
The Issue: Performing a system shutdown on VITROS XT 3400
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 3400 Chemistry System with Version 3.7.2 and below
The Issue: Performing a system shutdown on VITROS XT 3400
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power electronic box
The Issue: Screws mounting an internal power supply may come
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Alinity m System
The Issue: Incorrect optical calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro
The Issue: Negative bias with patient samples. The mean patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System
The Issue: Incorrect expiration date listed on the product labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.