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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

2,907 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 24, 2015 The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSo... The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. Class II EKOS Corporation
Jun 24, 2015 uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for r... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement o... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging in... Class II Stryker Howmedica Osteonics Corp.
Jun 24, 2015 HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ... Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. Class II Hardy Diagnostics
Jun 23, 2015 BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. ... Some of the tubes were manufactured with stoppers that did not meet current manufacturing specifi... Class III Becton Dickinson & Company
Jun 23, 2015 O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01... Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning devic... Class II O-Two Medical Technologies, Inc.
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Contour Next Control Solution for Contour Next Blood Glucose Test System. Li... If the control solution bottle is not thoroughly shaken prior to use, the control test result may... Class II Bayer Healthcare, LLC
Jun 22, 2015 Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine... the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fab... Class II Draeger Medical, Inc.
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutme... One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used t... Class II Nobel Biocare Usa Llc
Jun 19, 2015 Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number... Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, b... Class II Atrium Medical Corporation
Jun 19, 2015 MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), ... Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain ... Class II Medtronic MiniMed Inc.
Jun 19, 2015 Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage... Incorrect expiration date on outer carton kit label Class II CooperSurgical, Inc.
Jun 18, 2015 Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series ... Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipp... Class II Allergan Inc
Jun 18, 2015 Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series T... Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shippe... Class II Allergan Inc
Jun 18, 2015 Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 18, 2015 T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 17, 2015 Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduc... Probe programming error. The incorrect program can generate more heat at the surgical site, resu... Class II ConMed Corporation
Jun 17, 2015 Invivo Expression MRI Patient Monitoring System. The device's labeling inaccurately indicates Endotracheal as a body temperature application site.... Class II Philips Electronics North America Corporation
Jun 17, 2015 A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surg... Class II Biomet, Inc.
Jun 17, 2015 Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags inc... Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment. Class III Acon Laboratories, Inc.
Jun 17, 2015 Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 50... The product was marketed without 510(k) clearance. Class II Agilent Technologies, Inc.
Jun 17, 2015 ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fat... Class II Zimmer, Inc.
Jun 16, 2015 INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical Syste... Field Safety Notification to advise of an issue that may occur involving the combination of the d... Class II Intuitive Surgical, Inc.
Jun 16, 2015 SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. ... Lack of sterility assurance. Class II Symmetry Surgical, Inc.
Jun 16, 2015 Celsite Implantable Access Port System, model ST301. The Celsite Implantable... The manufacturer, B. Braun medical France, received endotoxin test results that are out of specif... Class II B. Braun Interventional Systems
Jun 15, 2015 Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extr... Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... Class II Sorin Group USA, Inc.
Jun 15, 2015 Block Versions Used by Dental Offices often referred to as chairside milling:... 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate produc... Class II 3M Company - Health Care Business
Jun 15, 2015 Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable an... The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The fi... Class II Etac Supply Center Ab
Jun 15, 2015 i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged ... Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs p... Class II Abbott Point Of Care Inc.
Jun 15, 2015 BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B... Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to th... Class III BD Biosciences, Systems & Reagents
Jun 15, 2015 Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biop... Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the... Class II Mermaid Medical A/S
Jun 15, 2015 Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control f... Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... Class II Sorin Group USA, Inc.
Jun 15, 2015 Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extr... Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... Class II Sorin Group USA, Inc.
Jun 15, 2015 Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extr... Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... Class II Sorin Group USA, Inc.
Jun 15, 2015 Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Scr... SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instrum... Class II Pega Medical Inc.
Jun 15, 2015 Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorpore... Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... Class II Sorin Group USA, Inc.
Jun 15, 2015 OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1... Software bug was found where there was no difference in Total and Corneal high-order aberrations,... Class II Nidek Inc
Jun 15, 2015 Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extr... Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if p... Class II Sorin Group USA, Inc.
Jun 12, 2015 GE Healthcare, Precision MPi fluoroscopic imaging systems. A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... Class II GE Healthcare
Jun 12, 2015 ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ASP-1020 LipoTower with Aspiration Pump. Medical use. There is potential risk of electrical shock if lead wires inside the device become detached and t... Class II MicroAire Surgical Instruments, LLC
Jun 12, 2015 ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: T... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surf... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 GE Healthcare Precision RXi Digital system A reported incident of a monitor that fell from the suspension. A fall of a monitor could result... 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.