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Browse Device Recalls

17 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 17 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 17 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 4, 2024 microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended us... A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigatio... Class I FHC, Inc.
Jun 17, 2020 FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to... An electrical sub-circuit was not properly connected. Its purpose is to eliminate the possibility... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System, Product Number 66-ZD-MD-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Prod... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System, Product Number MT-DS-01 The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-A... The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System, Product Number 66-ZD-MD The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" Drive System, Product Number MT-DS The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, Inc.
May 10, 2018 microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is o... Class II FHC, 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.