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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Elekta MONACO RTP Sytem, radiation treatment planning software system - Produ... The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour... Class II Elekta Inc
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 503... This product has been confirmed to exhibit holes in the packaging, which impacts package integrit... Class II Becton Dickinson & Company
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right,... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.
Apr 15, 2020 SureStep Foley Tray System - Product Usage: Intended for use in the drainage ... There is potential for a white paper-type residue attached to the catheter. Class II C.R. Bard Inc
Apr 15, 2020 Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Numb... The firm received complaints on five devices from one specific lot where the stent dislodged from... Class II Cook Inc.
Apr 14, 2020 BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential sta... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 14, 2020 BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorgan... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 14, 2020 BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorga... May exhibit increased levels of artifacts which could be difficult to distinguish from gram posit... Class II Becton Dickinson & Co.
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental u... Restorations crack during the sintering process. Class II Ivoclar Vivadent AG
Apr 13, 2020 Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumog... The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... Class II Philips North America, LLC
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The c... The labeling of the Philips Chest Pneumograph does not include a statement indicating that the pr... Class II Philips North America, LLC
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless St... The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together... Class II K2M, Inc
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems
Apr 13, 2020 Sterile Custom Packs to be used in surgical procedures. The surgical gowns were manufactured in a facility that is not registered by the FDA. Class II American Contract Systems

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.