Browse Device Recalls

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
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.
Feb 4, 2014 Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Feb 4, 2014 Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use ... Dialysate Port Leak During Priming of the Dialyzers Class II Fresenius Medical Care Holdings, Inc.
Jan 24, 2014 NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Cont... NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC ... Class II Hologic, Inc
Jan 24, 2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packa... Mislabeled product. Class II NxStage Medical, Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
Jan 17, 2014 MEDITECH Microbiology - Calculator/data processing module, for clinical use. Potential for patient results being removed from LAB/EMR. Class II Medical Information Technology, Inc.
Dec 18, 2013 ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 ... ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe... Class II Siemens Healthcare Diagnostics, Inc
Dec 18, 2013 ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 ... ADVIA Centaur¿ Systems Phenytoin Calibrator N, lots CN58 and higher, change in recovery observe... Class II Siemens Healthcare Diagnostics, Inc
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Inject... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injec... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 18, 2013 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects... Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo... Class II Boston Scientific Corporation
Dec 17, 2013 Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Pa... Bicarbonate Jug Adapter distributed prior to 510(k) approval Class II Fresenius Medical Care Holdings, Inc.
Dec 13, 2013 CODMAN CERTAS Programmable Valves, central nervous system shunt, models as fo... Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray im... Class II Codman & Shurtleff, 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.