Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated… Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box Class IIIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 2, 2020ClassClass IIIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Maryland, New Mexico, Nevada, New York and Pennsylvania named
- Medical device recall Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated… Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box Class IIIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 2, 2020ClassClass IIIStatusTerminatedWhereNationwide, and District of Columbia, Florida, Maryland, New Mexico, Nevada, New York and Pennsylvania named
- Medical device recall VITROS XT3400 Chemistry System When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS XT7600 Integrated System When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the… Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Klarity Vacuum Bags Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Massachusetts, New York and Pennsylvania named
- Medical device recall CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled,… The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Neurosign V4 Intraoperative Nerve monitor family of devices. Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 2, 2020ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Idaho, Louisiana, Montana, Nevada, Ohio, South Carolina, Wisconsin and West Virginia
- Medical device recall Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the… The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as “Left” for surgical plans for a… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray… Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Illinois, Maryland, Minnesota, North Carolina, Nebraska, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia and Wisconsin
- Medical device recall Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system… Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Illinois, Maryland, Minnesota, North Carolina, Nebraska, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia and Wisconsin
- Medical device recall BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction Manual: Z18444US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction Manual: Z18445US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible Intubation Video Endoscope, Part: 11302BDX, with Instruction Manual: Z18443US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are… Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of… E. Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as… When performing offline image review in RayCare 2C, RayCare 3A and RayCare 3B an offline image review task will guide you to the image viewer with the… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2020ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cobra x5 1-CH EMG ET Tube, 6.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cobra x5 1-Ch EMG ET Tube, 7.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cobra x5 1-Ch EMG ET Tube, 8.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cobra x5 2-Ch EMG ET Tube, 6.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cobra x5 2-Ch EMG ET Tube, 7.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cobra x5 2-Ch EMG ET Tube, 8.0mm The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage… Class IIFDA’s classSep 2, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 2, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19… While operating the machine in “Run” mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2020ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall ClosureFast Micro Introducer Sheath Set Sterile introducer sheath set manufactured under one lot with different expiration dates. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Mississippi named
- Medical device recall Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and… FDA revocation of the Emergency Use Authorization due to performance issues Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test for… FDA revocation of the Emergency Use Authorization due to performance issues Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Chembio DPP¿ Micro Reader II for use with the DPP¿ COVID-19 IgM/IgG System- Rapid immunochromatographic test… FDA revocation of the Emergency Use Authorization due to performance issues Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Phillips 3.7V Rechargeable Li-Polymer Battery, Product #: 989803191341 - Product Usage: This battery is used… A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the… A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Phillips Module Charger, Product #: 989803191031 - Product Usage: This Module Charger is used in the… A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the… Class IIFDA’s classAug 26, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia and Pennsylvania
- Medical device recall Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the… Class IIFDA’s classAug 26, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia and Pennsylvania
- Medical device recall PAPR (Powered Air-Purifying Respirator) The rivets that secure the elastic headband to the face shield have the potential to be mis-assembled. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportMichiganthe one state its words name PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for… May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length… Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Golden Technologies Suspect poor weld on back KD bar. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Single RIKKI Retractor The products were improperly heat treated. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Maryland, North Carolina, New York, Oklahoma, Pennsylvania, South Dakota, Tennessee, Washington and Wisconsin
- Medical device recall Positron Emission Tomography and Computed Tomography System In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when… Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and… Modular Junction Box (MJB) cables can melt and affect the bed functionality. Class IIFDA’s classAug 26, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 26, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kansas and Louisiana named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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