Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

26 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 26 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 26 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 4, 2024 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0... Unreleased software was installed on customer systems resulting in the visual feedback on the scr... Class II Stryker Leibinger GmbH & Co. KG
Mar 29, 2024 Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), ... Class II Stryker Leibinger GmbH & Co. KG
Dec 6, 2022 Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Device was shipped without having regulatory approval. Class II Stryker Leibinger GmbH & Co. KG
Dec 29, 2021 MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 Inside the packaging of one reported item a non-conforming product was found. Contrary to the des... Class II Stryker Leibinger GmbH & Co. KG
Apr 1, 2021 DirectInject consists of a sterile dual paste system which is calcium phospha... Inability for the user to inject the paste from the syringe into the target location. Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 1... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCRE... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Num... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Numb... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part N... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING S... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING ... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Jun 22, 2018 AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Nu... After a three year term, there is a potential for the external packaging (sterile barrier) to bec... Class II Stryker Leibinger GmbH & Co. KG
Oct 16, 2017 The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for re... Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial... Class II Stryker Instruments Div. of Stryker Corporation
Jan 3, 2017 QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain ... An incorrect sterility status on the label, non-sterile products labeled as sterile Class II Stryker Leibinger GmbH & Co. KG
Jan 3, 2017 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar ... An incorrect sterility status on the label, non-sterile products labeled as sterile Class II Stryker Leibinger GmbH & Co. KG

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.