Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Prevent G Safety Winged Blood Collection Set Glide Complain due to the hub needle came out when the nurse draw the blood and removed the tube. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 1, 2019ClassClass IIStatusOngoingWhereNationwide, and Kansas named
- Medical device recall Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4” Several lots of Jelco¿ ViaValve” safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an… Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CryoPatch SG Pulmonary Hemi-Artery Patch The device is recalled due to donor ineligibility of released human tissue. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereTexas
- Medical device recall St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude… The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, Tennessee, Texas and Wisconsin named
- Medical device recall Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes Class IIIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 1, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Florida and North Carolina named
- Medical device recall VITROS XT 7600 Integrated System One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Class IIFDA’s classMay 1, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 1, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Ohio, Texas and Virginia named
- Medical device recall Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )… In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall icumedical ChemoClave Vented Vial Spike, 20 mm There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall icumedical ChemoClave Vented Vial Spike, 20 mm There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall icumedical Oncology Kit w/12” Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall icumedical Oncology Kit w/12” There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall icumedical ChemoLock, 20mm, (a) There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall icumedical ChemoLock Closed Vial Spike w/Skirt, (a) There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall SetSource ChemoClave Vented Vial Spike, 20mm There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy. Complaints of the snare loop not completely retracting and/or misshaping of the snare loop. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall FilmArray BCID Panel, IVD Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report49 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall VICRYL Sutures VICRYL SUTURE 18”(45CM) 0 VIO VICRYL SUTURE 18”(45CM) 4-0 UND VICRYL SUTURE 18”(45CM) 2-0 VIO… VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18”(45CM) 3-0 VIO VICRYL PLUS SUTURE 18”(45CM) 0 UND VICRYL PLUS… VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PDS II SUTURE 18”(45CM) 2-0 VIO VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent… Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254,… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the… When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient’s thumbnails is completed, then the… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad Malfunction warming pad. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedApr 24, 2019ClassClass IIStatusCompletedWhereWisconsin
- Medical device recall Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal,… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Michigan, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003… Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal,… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Michigan, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce… Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional… Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional… Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bilirubin Total Gen.3 New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lactate Gen.2 New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tina-quant IgM Gen.2 New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOVENTUS Bioactive Bone Graft Putty 15g The firm became aware of the potential for the products’ sterile pouch to be punctured during transit. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oregon, Tennessee, Texas, Utah, Washington and Wyoming
- Medical device recall 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits Tray label indicates the kits are packaged with a 15F “valved” peelable introducer, but the kits contain a 15F “non-valved” peelable introducer. Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report20 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and West Virginia
- Medical device recall Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Tibial Total Ankle Prosthesis Tray, Size 0, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Tibial Total Ankle Prosthesis Tray, Size 1, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Tibial Total Ankle Prosthesis Tray, Size 2, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Tibial Total Ankle Prosthesis Tray, Size 3, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box… Class IIFDA’s classApr 24, 2019in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington 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.”
Your shortlist0 of 4
Add one more to compare.