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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.

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DateProductReasonClassFirm
May 27, 2015 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do ... Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full T... Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates o... Class III Bard Access Systems
May 26, 2015 CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Versio... Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the loc... Class II Smiths Medical ASD, Inc.
May 26, 2015 Medtronic Navigated Cannulated Taps Individual cannulated taps are package... Medtronic Navigation is initiating a field correction due to the potential for injury which could... Class II Medtronic Navigation, Inc.
May 26, 2015 Bausch & Lomb SofPort Advanced Optics Aspheric Lens Haptics breaking during lens loading and insertion. Class II Bausch & Lomb Surgical, Inc.
May 26, 2015 Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofP... Haptics breaking during lens loading and insertion. Class II Bausch & Lomb Surgical, Inc.
May 22, 2015 American Science & Engineering Inc,Gemini Cabinet X-ray system. During factory testing, we discovered that Gemini systems could, in rare circumstances, experienc... Class II American Science & Engineering, Inc.
May 22, 2015 Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego system... There exists a possible position sensor fault in the swivel base axis not being detected by the s... Class II Siemens Medical Solutions USA, Inc
May 22, 2015 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (... Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to compla... Class II Stryker Instruments Div. of Stryker Corporation
May 21, 2015 Sure T, contact, contact detach, neria, neria detach, neria multi and thalase... Unomedical has found that in rare cases the steel needle can break during use, interrupting the d... Class II Unomedical As
May 21, 2015 Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimensi... Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop process... Class II Siemens Healthcare Diagnostics, Inc.
May 21, 2015 Oncentra Brachy radiation therapy planning software designed to analyze and p... Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series. Class II Elekta, Inc.
May 21, 2015 Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)0084... Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored... Class II RTI Surgical, Inc. (dba Pioneer Surgical Techno...
May 21, 2015 Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical ... Shipped to a single consignee prior to completion of final inspection. Class II Exactech, Inc.
May 21, 2015 Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surg... The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of ... Class II Intuitive Surgical, Inc.
May 21, 2015 ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONN... Potential for a leak at the tubing to luer bond. Class II Baxter Healthcare Corp
May 21, 2015 Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpo... Shipped to a single consignee prior to completion of final inspection. Class II Exactech, Inc.
May 20, 2015 MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 A diaphragm size 80 labeled box was incorrectly packaged with a size 85. Class II CooperSurgical, Inc.
May 20, 2015 NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surge... Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. Class II Northern Digital Inc.
May 20, 2015 NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodial... Bacterial contamination. Class II Fresenius Medical Care Holdings, Inc.
May 19, 2015 ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500... System-to-system bias between the Tni-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVI... Class II Siemens Healthcare Diagnostics, Inc
May 19, 2015 VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The ... Use of the recalled product may result in false positive reports. Class II Remel Inc
May 19, 2015 VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The ... Use of the recalled product may result in false positive reports. Class II Remel Inc
May 19, 2015 CentraLink" Data Management System; software is a network solution provider a... Siemens Healthcare Diagnostics has determined that the sample query function that includes Instr... Class II Siemens Healthcare Diagnostics, Inc.
May 19, 2015 Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each... A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in ... Class II Pointe Scientific, Inc.
May 18, 2015 Ally Uterine Positioning System (Ally UPS) used in the mounting and position... Design of device may expose user to injury to fingers or body parts Class II CooperSurgical, Inc.
May 18, 2015 M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (meta... Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinecti... Class I Zimmer, Inc.
May 18, 2015 ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Plat... Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart ... Class II Edwards Lifesciences, LLC
May 18, 2015 ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Sta... The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabel... Class II Orthofix, Inc
May 18, 2015 The VariSource iX series afterloader systems are computer controlled remote e... After an application freeze and restart of the VariSource iX series by power cycling, the Partial... Class II Varian Medical Systems Inc
May 18, 2015 Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzi... Class II Varian Medical Systems Inc
May 18, 2015 ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5... Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature an... Class II Coreva Health Science LLC
May 15, 2015 Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an... Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class II Vascutek, Ltd.
May 15, 2015 Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catal... Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or hi... Class II Philips Ultrasound, Inc.
May 15, 2015 Syngo.via and Syngo.x ; a software solution intended to be used for viewing, ... measurements drawn on the 2nd and subsequent images of the series are not visible on printouts wh... Class II Siemens Medical Solutions USA, Inc
May 15, 2015 PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLAS... Potential component failure resulting in inoperability Class II ArthroCare Medical Corporation
May 15, 2015 MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bott... Vial to vial variation in the fill volume that could affect control recovery issues and cause a c... Class II MedtestDx, Inc.
May 15, 2015 Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an... Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class II Vascutek, Ltd.
May 15, 2015 Cell Search Circulating Tumor Kit. Intended for the enumeration of circulatin... Complaints of the presence of artifacts that appears as small bead like structures in the image g... Class II Veridex, LLC
May 15, 2015 EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA ... Potential component failure causing device inoperability Class II ArthroCare Medical Corporation
May 14, 2015 The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Opti... The pin which maintains the knob button, may disconnect and become lost. This may result in a de... Class II BIOMET FRANCE S.A.R.L.
May 14, 2015 Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Huds... The intake port may be blocked which can cause the bag to fail to fill. Class I Teleflex Medical
May 14, 2015 LapSac Surgical Tissue Pouch. The current intended use for the LapSac Sur... Includes Information not stated in the intended use. Class II Cook Inc.
May 13, 2015 StoneLight 30 Laser System (NS3000). For use in surgical procedures using ... During internal testing a situation was discovered where when changing the settings, a new settin... Class II New Star Lasers, Inc.
May 13, 2015 Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Us... An issue with the cancel functionality used during atypical infusion programming to cancel user i... Class II CareFusion 303, Inc.
May 13, 2015 Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression t... Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for... Class II Advanced Back Technologies, Inc.
May 13, 2015 Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for tra... Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for... Class II Advanced Back Technologies, Inc.
May 13, 2015 The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 261... The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the exp... Class III Bio-Rad Laboratories, Inc.
May 13, 2015 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm ... affected parts and lots of the Cannulated Drill Bits have the potential to break during use Class II Synthes, Inc.
May 13, 2015 SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An inte... Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have ... Class I Ethicon Endo-Surgery 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.