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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
Aug 11, 2015 Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrume... It was found through review of open Complaints and stock investigations that a single lot of Zimm... Class II Zimmer, Inc.
Aug 11, 2015 Centricity Universal Viewer Product Usage: The Centricity Universal Viewe... Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be ... Class II GE Healthcare
Aug 10, 2015 Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to ... RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, ... Class II Biomet 3i, LLC
Aug 10, 2015 Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attac... The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a squa... Class II Biomet 3i, LLC
Aug 10, 2015 CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reproc... Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the... Class II Advanced Sterilization Products
Aug 8, 2015 Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000);... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Mo... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model num... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Mode... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS300... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model n... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 8, 2015 Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model nu... In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip ... Class II Intuitive Surgical, Inc.
Aug 7, 2015 IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL... It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance... Class II International Biophysics Corp.
Aug 7, 2015 IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wan... It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance... Class II International Biophysics Corp.
Aug 7, 2015 CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a per... Software defect that impacts image alignment when using the automatic stitching option for long l... Class II Carestream Health Inc
Aug 7, 2015 IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH... It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance... Class II International Biophysics Corp.
Aug 7, 2015 CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line moni... Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a ... Class II Terumo Cardiovascular Systems Corporation
Aug 6, 2015 Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with I... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Thinflap System Case The cases hold surgical instrumentation in place during... The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... Class II Biomet Microfixation, LLC
Aug 6, 2015 Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Saf... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Strai... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Cur... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONL... The affected parts subject to the recall are out of specification, resulting in in the loss of th... Class II Trilliant Surgical Ltd.
Aug 6, 2015 Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions ... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Neuro Combo Set Case The cases hold surgical instrumentation in place during... The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user withou... Class II Biomet Microfixation, LLC
Aug 6, 2015 Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* S... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 5950... SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mec... Class I SynCardia Systems Inc.
Aug 6, 2015 Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile... Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) ... Class II Tornier, Inc
Aug 6, 2015 Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safet... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curve... Sterility may be compromised Class II Covidien LLC
Aug 6, 2015 Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Produ... Sterility may be compromised Class II Covidien LLC
Aug 5, 2015 ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to... ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructe... Class II Brainlab AG
Aug 5, 2015 The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departme... The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm ... Class III Leica Microsystems, Inc.
Aug 5, 2015 Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part ... The neoBLUE Instruction For Use (IFU) and Service Manuals for the neoBLUE 3 were revised to show ... Class II Natus Medical Incorporated
Aug 5, 2015 ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, P... A software fix has been released to prevent automatic movement resulting in a collision safety ri... Class II Siemens Medical Solutions USA, Inc
Aug 5, 2015 SurFlo IV Catheter According to the Terumo (TMC) this device is used to access the human peripheral vascular system ... Class II Terumo Medical Corporation
Aug 5, 2015 Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cer... Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. Class II Biomet Spine, LLC
Aug 5, 2015 Villa Sistemi Rotograph EVO 3D X-ray It has been discovered that due to lack of information accompanying documents the product fails t... Class II Villa Radiology Systems LLC
Aug 5, 2015 Owandy Radiology I -MAX Touch 3D X-ray It has been discovered that due to lack of information accompanying documents the product fails t... Class II Villa Radiology Systems LLC
Aug 4, 2015 NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebuli... The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or ... Class II Salter Labs
Aug 4, 2015 PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degr... Unexpected rate of postoperative fractures resulting in the need for revision surgery. Class I MicroPort Orthopedics, Inc.
Aug 4, 2015 Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilize... Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional Ne... Class II Bayer Healthcare
Aug 3, 2015 Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Wee... The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying ... Class II Medline Industries Inc
Aug 3, 2015 Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene o... Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. Class II Medivators, Inc.

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.