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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Oct 11, 2018 St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6... The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed w... Class II St. Jude Medical, Inc.
Mar 9, 2018 Proclaim DRG Implantable Pulse Generator, Model Number 3664 The firm received complaints of error messages that occurred during routine impedance checks on P... Class II St. Jude Medical, Inc.
Sep 12, 2017 Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable... Analysis of the difference between the actual device longevity and the battery indicator status p... Class II St. Jude Medical, Inc.
Sep 12, 2017 Proclaim DRG Implantable Pulse Generator Model 3664 Analysis of the difference between the actual device longevity and the battery indicator status p... Class II St. Jude Medical, Inc.
Sep 12, 2017 Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Gener... Analysis of the difference between the actual device longevity and the battery indicator status p... Class II St. Jude Medical, Inc.
Jun 2, 2017 Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO ... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO ... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, P... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jun 2, 2017 Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Pro... The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monop... Class II St. Jude Medical, Inc.
Jul 29, 2014 Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as p... The Directions for Use (DFU) manual contains information for devices that are not approved in the... Class II St. Jude Medical, Inc.
Jul 29, 2014 Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as p... The Directions for Use (DFU) manual contains information for devices that are not approved in the... Class II St. Jude Medical, 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.