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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

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Clear
DateProductReasonClassFirm
May 23, 2013 Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, E... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single u... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; si... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: Th... The product does not meet the firm's size standards, the product was produced in the incorrect size. Class II Prism Medical Services USA
May 23, 2013 Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single us... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; singl... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
May 23, 2013 Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 430... This is a recall expansion from the 2010 recall which now includes seven additional lots that wer... Class II Zimmer, Inc.
May 23, 2013 ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The... Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the... Class II Sotera Wireless, Inc.
May 22, 2013 Monaco RTP System Radiation Therapy Treatment Planning System. Radiation ... Patient needs to be positioned as indicated by the treatment plan. Class II Elekta, Inc.
May 21, 2013 GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedic... Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. Class II Stryker Howmedica Osteonics Corp.
May 21, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Cor... leaking pouches Class II Baxter Healthcare Corp.
May 20, 2013 STERIS Fine Traction Device, one unit per box Product Usage: The Fine Tra... A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-re... Class II Steris Corporation
May 20, 2013 Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tiss... There is a possibility that the pump head was not shipped in the locked position. If the pump he... Class II Olympus America Inc.
May 20, 2013 Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - l... There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample dil... Class II Siemens Healthcare Diagnostics, Inc.
May 17, 2013 BASE, S-LIFT Instrument Case Product Usage: System cases are designed to... The S-LIFT Instrument Case contained a bracket with peeling nylon coating. Class II SpineFrontier, Inc.
May 17, 2013 Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Te... RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Managemen... Class II RF Technologies, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound... Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user... Class II U-systems Inc
May 16, 2013 CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by p... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 16, 2013 CoaguChek XS Plus System The CoaguChek XS Plus system for use by professio... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Catheter and Accessories ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Potential to electrostatic discharged (ESD) Class II HeartWare Inc
May 16, 2013 Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device ... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Cathe... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Uniti... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the ... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Cat... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Cathet... Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class II Codman & Shurtleff, Inc.
May 16, 2013 Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device wit... Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick ... Class II The Standing Company
May 16, 2013 CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro mete... Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek X... Class II Roche Diagnostics Operations, Inc.
May 15, 2013 Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data E... During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-1... Class II Cincinnati Sub-Zero Products Inc
May 15, 2013 AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicate... Customers could potentially experience intermittent, unintended and illogical movement when using... Class II AGFA Corp.
May 15, 2013 Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 310... Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard ... Class II Maytex Corp
May 15, 2013 Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Conta... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-6... Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/le... Class II Tosoh Smd Inc
May 15, 2013 Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Prod... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8... The data printed on the thermal printer may omit a digit or decimal point in the results or sampl... Class II Sysmex America Inc
May 15, 2013 Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Contai... A firm's internal investigation led to the discovery of pinholes in the packaging of the products... Class II Baxter Healthcare Corp.
May 15, 2013 Superior Approach Resection Guide Assembly. Indicated for primary, fractur... Biomet has initiated this action following an investigation which identified that the slot on the... Class II Biomet, Inc.
May 14, 2013 Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liqui... It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks li... Class II Penlon, Ltd.
May 14, 2013 QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (2... Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during... Class II Edwards Lifesciences, LLC
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic ... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 104936... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 ADVIA Centaur¿ iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitr... iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability Class II Siemens Healthcare Diagnostics, Inc
May 14, 2013 Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or ... GE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 ab... Class II GE Healthcare, LLC
May 14, 2013 MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and ster... The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain... Class II Maquet Cardiovascular Us Sales, Llc
May 14, 2013 Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... Class III Optovue, 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.