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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

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
Jun 7, 2018 GE Healthcare MRI Systems, Software Version 11.x, sold under the following pr... The latest on-site software version may not have been reinstalled at some sites after service act... Class II GE Medical Systems, LLC
Jun 6, 2018 RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, ... The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous... Class II RAYSEARCH LABORATORIES AB
Jun 6, 2018 G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 ... HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Cu... Class II Tosoh Bioscience Inc
Jun 6, 2018 Single Chamber Temporary External Pacemaker, Model 53401 A subset of Medtronic Model 53401 Single Chamber External Pulse Generators (EPGs) may revert from... Class II Medtronic Inc., Cardiac Rhythm and Heart Failur...
Jun 6, 2018 Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the fol... GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclea... Class II GE Medical Systems, LLC
Jun 5, 2018 Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0... Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported Class II Stryker Neurovascular
Jun 5, 2018 Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... Distribution of unapproved product labeling Class III Tosoh Bioscience Inc
Jun 4, 2018 Leica Microsystems products labeled as the following: Leica M320 Microscope S... Possible failure of screws which hold the gas spring fixation bracket in place. Due to this fail... Class II Leica Microsystems, Inc.
Jun 4, 2018 Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device i... Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head ... Class II Fx Solutions
Jun 4, 2018 26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog N... There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a ... Class II B. Braun Medical, Inc.
Jun 4, 2018 EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. ... The firm has identified the potential for a silicone particle to be generated within the Suction ... Class II Intuitive Surgical, Inc.
Jun 4, 2018 Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device... Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head ... Class II Fx Solutions
Jun 4, 2018 EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofu... Mislabeled product Class III Richard-Allan Scientific Company
Jun 4, 2018 BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is i... The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorr... Class II CryoLife, Inc.
Jun 4, 2018 NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr... Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only ... Class II Neomed Inc
Jun 1, 2018 Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured b... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1... Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visu... Class II Medtronic Navigation, Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The S... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by:... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured b... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The S... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SG... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
May 31, 2018 VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Pro... This lot of VentriClear failed endotoxin testing. Potential adverse events include immune respon... Class II Cook Inc.
May 31, 2018 N Latex CDT Kit Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transf... Class II CSL Behring GmbH
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-77... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a di... When using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specif... Class II Canon Medical System, USA, INC.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL ... Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufactu... Class II Baxter Healthcare Corporation
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 30, 2018 ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000 During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotatio... Class II Siemens Medical Solutions USA, Inc
May 30, 2018 Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size ... M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior... Class II Zimmer Biomet, Inc.
May 29, 2018 Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 ... Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our su... Class II Siemens Medical Solutions USA, Inc.
May 29, 2018 Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Pl... Cap may be mislabeled with incorrect part number, although the correct part number is on the main... Class II Implant Direct Sybron Manufacturing, LLC
May 29, 2018 Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope Under certain circumstances, the firmware makes it possible for the Disinfection unit UV (432332-... Class II Zeiss, Carl Inc
May 28, 2018 EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. Underfilled reagent well that could lead to incorrect results Class II QIAGEN
May 25, 2018 ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX A... The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take pla... Class II Radiometer America Inc
May 25, 2018 Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Art... Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w... Class II Siemens Medical Solutions USA, 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.