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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 11 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 9, 2014 Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene ... Nanosphere Inc. has recently determined through four customer complaints that a small number of V... Class II Nanosphere, Inc.
Apr 17, 2014 Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed usi... Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an ele... Class II Nanosphere, Inc.
Mar 18, 2014 Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists... Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when ... Class III Nanosphere, Inc.
Oct 16, 2013 Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid... Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Inte... Class III Nanosphere, Inc.
Oct 10, 2013 The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene S... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Jun 17, 2013 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.
Jun 17, 2013 Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Car... There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence... Class II Nanosphere, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.