Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)… Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia and Illinois named
- Medical device recall Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended… Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia and Illinois named
- Medical device recall STAPLER,IS4000 Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and /… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAPLER 30,IS4000 Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and /… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CURVED-TIP STAPLER 30,IS4000 Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and /… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Geo-Med, TURP/CYSTO PACK PGYBK The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereLouisiana and Tennessee
- Medical device recall DeRoyal (R) CYSTO TRAY PGYBK The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereLouisiana and Tennessee
- Medical device recall NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a… WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereCalifornia, Louisiana, Texas and Wisconsin
- Medical device recall PCR Compano Basic Reader using 100-127V as mains voltage A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report41 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips DuraDiagnost stationary X-ray system Buttons or keys on the monitor allow the user to turn the volume setting down to 0”, in which case the beep will not be heard at the conclusion of an… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereCalifornia, Maine, North Carolina, Nebraska, Ohio, Oregon, Texas and Washington
- Medical device recall MAQUET Servo Humidifier 163, Inmed Mfg Cracking may occur at the 15mm and 22mm ISO female connector. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereFlorida, Kansas and West Virginia
- Medical device recall INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. Integra LifeSciences is recalling Spinal Trays, Cat No. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereCalifornia and Ohio
- Medical device recall RadSuite software Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereColorado and Oklahoma
- Medical device recall iConnect Enterprise Archive Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereColorado and Oklahoma
- Medical device recall Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 Some of the individual extension set packages were improperly sealed, compromising the sterility of the product. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois, Kansas, Kentucky, Michigan, Missouri, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and West Virginia
- Medical device recall Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T… A diode was inadvertently not assembled into the system, which may result in coil overheating Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereWisconsin
- Medical device recall A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a… Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Massachusetts, Maryland, Minnesota, Missouri, Nebraska, New Jersey, Oklahoma, Oregon, Pennsylvania and Virginia named
- Medical device recall FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm… If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereHawaii and North Carolina
- Medical device recall HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient… Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Pennsylvania and Washington named
- Medical device recall UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3… Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Illinois, Massachusetts, Michigan, New York, Texas and Washington
- Medical device recall Double Pump RF Patient Cassette Sterility of device may be compromised due to sterile package breakage. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as… Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SMR allen wrench 5 mm Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens… The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Merge Cardio software A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Push Button Blood Collection Set, Sterile Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SPECULAR MICROSCOPE CEM-530 Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Indiana, Kansas, Kentucky, Louisiana, Missouri, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation… In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session,… Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report40 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas,… Arterial Blood Gas (ABG) Kit- Missing Safety Component. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio PT/INR System Professional Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall INRatio Prothrombin Time (PT) Monitoring System Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio Replacement Monitor Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio2 PT/INR Professional Testing System Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio2 PT/INR Home Monitoring System Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio2 Replacement Monitor (Home) Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio2 PT/INR Professional Monitoring System Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio PT/INR Test Strips Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring Systems (Test Strips and Meters). FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alere INRatio/ INRatio2 PT/INR Test Strips Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Test Strips. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Roadrunner Uniglide Hydrophilic Wire Guide Potential coating contamination with glass particles. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 31, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10’ A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10’ A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on… A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS)… A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a… Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Large QWIX Compression screw, dia. 7.5 mm L 90 mm Labeling on the Qwix Screw product states that it is a “compression screw” instead of a “positioning screw”. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Georgia, Idaho, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Virginia and Washington named
- Medical device recall Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States Class IIIFDA’s classAug 31, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 31, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Massachusetts, New Jersey, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Medtronic, Lead Kit for DBS Stimulation Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. Class IIFDA’s classAug 31, 2016in FDA’s Enforcement Report11 statesnamed in where it went PublishedAug 31, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Illinois, Maryland, Missouri, Nebraska, New York, Ohio, Tennessee and Wisconsin
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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