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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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Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

Clear
DateProductReasonClassFirm
Oct 9, 2014 Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is i... Cleaning process validation failure. Class II Zimmer, Inc.
Oct 8, 2014 Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in ... Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for ... Class II Edwards Lifesciences, LLC
Oct 7, 2014 The Persona Tibial Articular Surface Inserter is a sterilizable instrument in... Affected product did not undergo heat treatment hardening step leading to the potential for defor... Class II Zimmer, Inc.
Oct 7, 2014 Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone baske... The product is non-sterile. Class II C.R. Bard, Inc.
Oct 1, 2014 APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plate... A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of... Class II Medartis, Inc.
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... A software issue may lead to ventilator inoperative situations. Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Sep 17, 2014 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 17, 2014 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 16, 2014 Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 16, 2014 Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 15, 2014 Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage Sys... tubing within the system that drains CSF may leak or disconnect from the joints and may result in... Class II Codman & Shurtleff, Inc.
Sep 15, 2014 Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Sy... tubing within the system that drains CSF may leak or disconnect from the joints and may result in... Class II Codman & Shurtleff, Inc.
Sep 15, 2014 Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System)... tubing within the system that drains CSF may leak or disconnect from the joints and may result in... Class II Codman & Shurtleff, Inc.
Aug 19, 2014 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Contr... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, Inc.
Aug 15, 2014 Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174A... Medtronic has decided to discontinue production and distribution of this low-volume product. Class II Medtronic Cardiovascular Surgery-the Heart Valv...
Aug 14, 2014 SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The ... SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because t... Class II Sam Medical Products
Aug 13, 2014 RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for pat... Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval noti... Class II Smith & Nephew, Inc.
Aug 13, 2014 V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (... Reports of deterioration of material covering the articulating section of the V5Ms transesophagea... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2014 eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA... Two (2) failures of the spring link components within the articulated arm assembly. The spring li... Class II Gendex Corp
Aug 7, 2014 PERSONA The Personalized Knee System Tibial Articular Surface Provisional Lef... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System Constrained Tibial Articular Surface Pro... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional ... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 7, 2014 PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional... Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona... Class II Zimmer, Inc.
Aug 5, 2014 CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes a... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefil... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Aug 5, 2014 Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefill... ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit pa... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flu... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stri... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 0... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Mac... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device a... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and ... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valv... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 18, 2014 Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze... ICU has become aware of an issue with a component where the connection on an arterial monitoring ... Class II ICU Medical, Inc.
Jul 11, 2014 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TK... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr... Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which... Class II Medtronic Neuromodulation
Jul 11, 2014 Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 7, 2014 H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediat... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric ... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediat... The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, Inc.
Jul 7, 2014 H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause ... Class I Smiths Medical ASD, 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.