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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

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class II Microline Surgical, Inc.
May 12, 2014 Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusab... Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw Class II Microline Surgical, Inc.
May 9, 2014 Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Staining on hip implant. Class II Omnilife Science Inc.
May 8, 2014 Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 3115... Straps may separate from the foam pad. Class II Covidien LLC
May 6, 2014 Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannula... Contains a sharp tip needle when the product should contain a blunt tip cannula Class II Beaver-Visitec International Inc.
May 5, 2014 All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R... In spine clinical workflows, cross reference lines may be used to determine the position of slice... Class II Philips Medical Systems, Inc.
May 1, 2014 NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with ... Container cap may contain foreign material- 0.60% - 0.80% Manganese Class III Fresenius Medical Care Holdings, Inc.
Apr 25, 2014 Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and... 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disco... Class II Fresenius Medical Care Holdings, Inc.
Apr 25, 2014 Revision K Actuator Test Boards sold as replacement parts for use with Frese... 2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disco... Class II Fresenius Medical Care Holdings, Inc.
Apr 22, 2014 SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with t... The hose could separate from the blanket. Class II Smiths Medical ASD, Inc.
Apr 14, 2014 Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product ... Grasper jaw may break when force is applied to the jaw Class II Microline Surgical
Apr 10, 2014 Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-... Naturalyte Liquid Bicarbonate maybe contaminated Class I Fresenius Medical Care Holdings, Inc.
Apr 10, 2014 ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. ... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemen... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 103... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 0649... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021.... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 10, 2014 ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 1069920... Samples containing fluorescein may show interference with the ADVIA Centaur¿ Systems TSH3 Ultra, ... Class II Siemens Healthcare Diagnostics, Inc
Apr 8, 2014 Intended for both adult and pediatric patients for taking diagnostic radiogra... In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an un... Class II Philips Medical Systems, Inc.
Apr 4, 2014 Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitor... The risk of battery failure increases with age, when a battery remains in use longer than 3 years... Class II Philips Medical Systems, Inc.
Apr 2, 2014 Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software appli... Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density ... Class II Philips Medical Systems, Inc.
Apr 2, 2014 Philips HeartStart XL+ Defibrillator/Monitor with system software version B.... Software communication failure may occur on the HeartStart XL+ locking the user out of clinical m... Class II Philips Medical Systems, Inc.
Mar 31, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automati... A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the abili... Class II Philips Medical Systems, Inc.
Mar 28, 2014 Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE... Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ C... Class II Terumo Cardiovascular Systems Corp
Mar 25, 2014 Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat... Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift i... Class II Siemens Healthcare Diagnostics, Inc
Mar 17, 2014 Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended f... Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the ... Class II Smiths Medical ASD, Inc.
Mar 17, 2014 Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50... The footboard of Patient support for stitching can be fixed in upper position. When the fix clam... Class II Philips Medical Systems, Inc.
Mar 17, 2014 Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended... Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the ... Class II Smiths Medical ASD, Inc.
Mar 5, 2014 Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor W... Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used Class II ZOLL Medical Corporation
Mar 5, 2014 MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Pr... Geometric positioning error can occur after a rotational correction has been applied to one or mo... Class II Mevion Medical Systems, Inc.
Feb 21, 2014 MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.0... Potential for erroneous result reporting. Class II Medical Information Technology, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J... ECG trunk cable and connector block of the MRx could be susceptible to accelerated wear, which co... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J... Philips HeartStart MRx Monitor/Defibrillator, when operating on battery power only, may experienc... Class II Philips Medical Systems, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A,... MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the... Class II Philips Medical Systems, Inc.
Feb 18, 2014 HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M... A component of the MRx Processor Board may be susceptible to damage from electrostatic discharge ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with ... When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may ... Class II Philips Medical Systems, Inc.
Feb 18, 2014 M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart M... Wireless Link may be unable to transmit data when configured for a specific data flow. Class II Philips Medical Systems, Inc.
Feb 14, 2014 Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Produc... Philips HeartStart XL may experience a power board failure causing failure to defibrillate Class II Philips Medical Systems, Inc.
Feb 6, 2014 Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... Incorrect master label. Class III Medtronic Vascular
Feb 4, 2014 Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use a... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M... HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing... Class II Philips Medical Systems, Inc.
Feb 4, 2014 Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute o... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, 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.