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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

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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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
Jun 3, 2015 Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and... Administration of inappropriate quantities of fluid can result, with the potential to cause injur... Class I Elite Biomedical Solutions LLC
Jun 3, 2015 Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and... Administration of inappropriate quantities of fluid can result, with the potential to cause injur... Class I Elite Biomedical Solutions LLC
Jun 3, 2015 SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Prob... Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of f... Class II Stryker Endoscopy
Jun 3, 2015 Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 ... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Us... Product may breach the inner and outer sterile pouches during shipping or handling. Class II Omnilife Science Inc.
Jun 3, 2015 Gentle Threads Interference Screw 10x25mm Round Head. An interference fixa... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
Jun 3, 2015 Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-... Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class II Perkinelmer
Jun 3, 2015 Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx on... The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which w... Class II Smith & Nephew, Inc.
Jun 3, 2015 Gentle Threads Interference Screw 9x35mm Full Thread. An interference fix... Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed wit... Class II Biomet, Inc.
Jun 2, 2015 Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo... Insufficient seal on the outside packaging, potentially affecting the sterility of the product. Class II Alcon Research, Ltd.
Jun 2, 2015 CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, ... Boston Scientific has received complaints indicating that, when using the blood pressure (BP) cha... Class II Boston Scientific Corporation
Jun 2, 2015 EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable ... Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (H... Class II ArthroCare Corporation
Jun 2, 2015 Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: ... Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the p... Class II Stryker Instruments Div. of Stryker Corporation
Jun 1, 2015 HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 2... The double swivel connector may crack or separate on the endobronchial tube. Class I Teleflex Medical
Jun 1, 2015 HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, ... The double swivel connector may crack or separate on the endobronchial tube. Class I Teleflex Medical
Jun 1, 2015 HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used... The double swivel connector may crack or separate on the endobronchial tube. Class I Teleflex Medical
Jun 1, 2015 Laksell GammaPlan, a computer based dose planning system specifically designe... Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. Class II Elekta, Inc.
Jun 1, 2015 Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179.... An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ven... Class II Hamilton Medical, Inc.
Jun 1, 2015 Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. I... Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... Class II Stryker Sustainability Solutions
Jun 1, 2015 Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR7... Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... Class II Stryker Sustainability Solutions
Jun 1, 2015 Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500... An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ven... Class II Hamilton Medical, Inc.
Jun 1, 2015 Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177.... An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ven... Class II Hamilton Medical, Inc.
Jun 1, 2015 Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36... Sechrist Industries is recalling the Sechrist Low Profile Wheeled Stretcher because it may experi... Class II Sechrist Industries Inc
Jun 1, 2015 Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. ... Stryker Sustainability Solutions is recalling Trocars because they have received reports indicati... Class II Stryker Sustainability Solutions
Jun 1, 2015 HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: ... The double swivel connector may crack or separate on the endobronchial tube. Class I Teleflex Medical
May 31, 2015 The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2... Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to f... Class II Merge Healthcare, Inc.
May 29, 2015 Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Steril... The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of imp... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 29, 2015 AGFA DX-D 100 is a mobile digital radiography x-ray system When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge ... Class II AGFA Healthcare Corp.
May 29, 2015 GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 20... A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class II Tecan US, Inc.
May 29, 2015 InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calciu... Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection P... Class II Skeletal Kinetics, Llc
May 29, 2015 GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiograph... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 ... Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size ... Class II Stryker Howmedica Osteonics Corp.
May 29, 2015 GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 Radiation Therapy Treatment Planning System software RayStation is a softw... An error caused by a floating point precision problem tends to cause a problem with the display o... Class II RAYSEARCH LABORATORIES AB
May 29, 2015 GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance... Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our EL... Class II Mortara Instrument, Inc
May 29, 2015 Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite... A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class II Tecan US, Inc.
May 29, 2015 The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light syst... Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the j... Class II Maquet Cardiovascular Us Sales, Llc
May 29, 2015 Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M... A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class II Tecan US, Inc.
May 29, 2015 Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infini... A firmware bug causes incorrect values to be displayed for specific measured luminescence values. Class II Tecan US, Inc.
May 29, 2015 GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generatin... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare
May 29, 2015 GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in genera... GE Healthcare has recently become aware of a potential safety issue that may result in the loss o... Class II GE Healthcare

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.