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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

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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.

Clear
DateProductReasonClassFirm
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pedia... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 23, 2020 ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standal... Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detectio... Class II Siemens Medical Solutions USA, Inc
Apr 23, 2020 BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max B... Saline Flush Syringe compromised sterility due to holes in the packaging. Class II Access Scientific LLC
Apr 22, 2020 PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only S... Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... Class II BIOSENSE WEBSTER
Apr 22, 2020 ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Pro... If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may ... Class II Siemens Medical Solutions USA, Inc
Apr 22, 2020 Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for u... This field correction is being initiated to address potentially damaged seals in the packaging of... Class II LABORIE MEDICAL TECHNOLOGIES, CANADA ULC
Apr 22, 2020 smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured ... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERI... Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempt... Class II BIOSENSE WEBSTER
Apr 22, 2020 smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, man... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manu... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured ... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in ... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 22, 2020 smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, man... A manufacturing error resulted in out of specification R3 Acetabular Shells Class II Smith & Nephew, Inc.
Apr 21, 2020 BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pa... The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material numbe... Class II Bio-Rad Laboratories, Inc.
Apr 21, 2020 Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus P... Signature from the user is necessary to proceed with specific actions in the Proton Therapy Syste... Class II Ion Beam Applications S.A.
Apr 21, 2020 Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product ... HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and receiv... Class II Philips North America, LLC
Apr 20, 2020 Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, B... Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during cli... Class II Bovie Medical Corporation
Apr 20, 2020 Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Us... Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2020 Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product ... Three products requiring refrigerated storage conditions were incorrectly stored outside of appro... Class II Cardinal Health Inc.
Apr 20, 2020 B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is... Three products requiring refrigerated storage conditions were incorrectly stored outside of appro... Class II Cardinal Health Inc.
Apr 20, 2020 Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy. Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD. Class II ROi CPS LLC
Apr 20, 2020 Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-... Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during cli... Class II Bovie Medical Corporation
Apr 20, 2020 Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an... Internal Paddles may wear over time and may not be safe or ready for use, unless the directions i... Class II Philips North America, LLC
Apr 20, 2020 Oscar 2, Model 250 System The device display, when activated, can show an incorrect decimal point when the blood pressure r... Class II Suntech Medical, Inc.
Apr 20, 2020 Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Al... Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2020 Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere P... Three products requiring refrigerated storage conditions were incorrectly stored outside of appro... Class II Cardinal Health Inc.
Apr 20, 2020 Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios A... Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-a... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2020 TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended... One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a ... Class II Trividia Health, Inc.
Apr 17, 2020 Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 17, 2020 Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10... The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... Class II Siemens Medical Solutions USA, Inc
Apr 17, 2020 Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product ... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 17, 2020 Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regene... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-P... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 ... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 17, 2020 Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 ... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-103... The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsaf... Class II Siemens Medical Solutions USA, Inc
Apr 17, 2020 Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 M... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibia... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 1... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ M... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYL... Incorrect IOL diopter Class II Alcon Research LLC
Apr 17, 2020 Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Const... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysi... Potential disconnection of tubing set. Class II Baxter Healthcare Corporation
Apr 16, 2020 Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 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 66 left, ... The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging whi... Class II Howmedica Osteonics Corp.

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.