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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
Nov 4, 2019 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: ... The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain th... Class II Trilliant Surgical, LLC
Oct 10, 2019 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Steri... Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL0... Class II Trilliant Surgical, LLC
Mar 14, 2019 Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver... A screwdriver used to facilitate implant insertion and removal was found to be out of specificati... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning Sterilization Protocol for Trillia... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC

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.