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 5, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051 Some of the Stop Solution bottles, a caustic solution, have been reported to leak. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusOngoingWhereAlabama, California, Florida, Illinois, Kansas, Louisiana, Mississippi, New Jersey, New York, South Carolina, Texas, US Virgin Islands and Washington
- Medical device recall Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No Recalled by FDA on Nov 6, 2019 Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Convex Two-Piece Ostomy System (Skin Barrier) ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SPROTTE Lumbar with Introducer, labeled as the following: 1 Problem with packaging sealing process which affects sterility. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin and Wyoming named
- Medical device recall Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version… NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version… NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version… NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version… NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall A&E Medical Thorecon Plating System Kits Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Mississippi, New Mexico, Oklahoma, South Carolina, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall A&E Medical Thorecon Plating System Kits Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Mississippi, New Mexico, Oklahoma, South Carolina, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall A&E Medical Thorecon Plating System Kits Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Mississippi, New Mexico, Oklahoma, South Carolina, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall A&E Medical Thorecon Plating System Kits Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Mississippi, New Mexico, Oklahoma, South Carolina, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall A&E Medical Thorecon Plating System Kits Some Thorecon disposable tensioners supplied in different Plating System Kits exhibit a molding defect which occludes the through-channel for cable tensioning,… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Mississippi, New Mexico, Oklahoma, South Carolina, Texas, Utah, Vermont, Washington and Wisconsin
- Medical device recall TherMax Blood Warmer Unit TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Georgia and Maryland named
- Medical device recall SAROS Oxygen System There is an electronics control issue that causes the unit to not power on with battery power only. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EndoWrist Suction Irrigator, Single Use Instrument The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use. Product was manufactured utilizing an expired inner body. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, Florida, Minnesota and Missouri
- Medical device recall Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25 BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereArkansas, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, New York, Ohio, Tennessee, Texas and Virginia
- Medical device recall Port full Access Tray Supplier initiated recall of the GRIPPER Needles Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Maintenance Flush Kit/Blood Draw Supplier initiated recall of the GRIPPER Needles Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Kit, Port Access Supplier initiated recall of the GRIPPER Needles Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall PORT ACCESS INFUSION KIT - 1” NEEDLE Supplier initiated recall of the GRIPPER Needles Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall CardioLab/ComboLab Recording Systems Potential for failure of the patient leakage current test. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Various products which were contract sterilized. The contract sterilizer did not have adequate packaging data to support the 2-year shelf life. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 6, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Colorado, Florida, Indiana, Kentucky, Mississippi, North Carolina, Ohio, South Carolina, Tennessee and Texas named
- Medical device recall Dario Blood Glucose Monitoring System The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading. Class IIFDA’s classNov 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Implant Direct Scan Adapter Assembly Replant platform for the following The action is being initiated due to incorrect assembly of the scan adapter . Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report14 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Louisiana, Massachusetts, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Utah and Virginia
- Medical device recall POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows Complaints were received on the product, such as the re-breather bag would not fill/inflate or the oxygen line pops off after the oxygen is turned on due to a… Class IIFDA’s classNov 6, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 6, 2019ClassClass IIStatusTerminatedWhereCalifornia, Florida, Missouri, Ohio and Pennsylvania
- Medical device recall Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams,… An error can occur when performing a biopsy using the InSpect function. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel) The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Massachusetts and Pennsylvania
- Medical device recall OptiLITE, Products for Laser Surgery It has been determined that a lot of fiber lasers were programmed incorrectly. Class IIIFDA’s classOct 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 30, 2019ClassClass IIIStatusTerminatedWherePennsylvania and Virginia
- Medical device recall IMRIS MR/X-ray head fixation device Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result… Class IIFDA’s classOct 30, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereFlorida, New Hampshire and Tennessee
- Medical device recall Rifton TRAM Standard Base A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rifton TRAM Low Base A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rifton E-Pacer A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following Potential ability to leak once used for compounding. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, 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 Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe… Potential for the wire to fracture at the threads and remain in the glenoid. Class IIFDA’s classOct 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedOct 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Minnesota, New York, Ohio, South Carolina, Tennessee, Texas, Virginia and Washington 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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