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 Kit BD Max ExK TNA 2 The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max MRSA The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Enteric Parasite Panel EU The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Enteric Bacterial Panel EU The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max CT/GC/TV The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max StaphSR The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max StaphSR The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max MRSA XT The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max GC RT PCR Assay The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Vaginal Panel The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Enteric Viral Panel RUO The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit EXT Enteric Bacterial Panel The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Kit BD Max Enteric Viral Panel EU The foil bags containing extraction tubes for BD MAX” Reagent products may not been sealed properly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report38 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX… Visual particulates within a battery Tyvek pouch. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Michigan and Texas named
- Medical device recall N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in… Iincreased (falsely elevated) Albumin results compared to expected results Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAGNETOM Aera magnetic resonance diagnostic devices Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MAGNETOM Skyra magnetic resonance diagnostic devices Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MAGNETOM Spectra magnetic resonance diagnostic devices Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MAGNETOM Prisma magnetic resonance diagnostic devices Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report42 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ZYMUTEST HIA MonoStrip, IgG ELISA kit Residual crystallization of the microplate and recurrent negative controls out of range. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNorth Carolina, New Hampshire, New York and Ohio
- Medical device recall ZYMUTEST HIA MonoStrip, IgGAM ELISA kit Residual crystallization of the microplate and recurrent negative controls out of range. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNorth Carolina, New Hampshire, New York and Ohio
- Medical device recall Thoratec HeartMate 3 LVAS Implant Kit, Sterile Outflow Graft leaking at the pump connection during the implantation process. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile Outflow Graft leaking at the pump connection during the implantation process. Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON NX2 Diagnostic Ultrasound System The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 28, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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 ACUSON NX2 Elite Diagnostic Ultrasound System The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 28, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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 ACUSON NX3 Diagnostic Ultrasound System The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 28, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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 ACUSON NX3 Elite Diagnostic Ultrasound System The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 28, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, 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 Luer Lock Set Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters,… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 28, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Microdot Xtra blood glucose test strips The firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly “notch” BG test… Class IIFDA’s classAug 28, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 28, 2019ClassClass IIStatusOngoingWhereIllinois
- Medical device recall VOLUMAT MC AGILIA US, Infusion Pump The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Vigilant Agilia, Vigilant Drug’Lib The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Medline Primary Warmer Pack, Product No The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 21, 2019ClassClass IStatusTerminatedWhereIllinois
- Medical device recall Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 21, 2019in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 21, 2019ClassClass IStatusTerminatedWhereIllinois
- Medical device recall iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 Potential for iGUIDE to incorrectly monitor the 3D position. Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Orthopedic Salvage System (OSS) Hybrid Poly Tibia Cleaning processes potentially being ineffective Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina and Texas
- Medical device recall Orthopedic Salvage System (OSS) Hybrid Poly Tibia Cleaning processes potentially being ineffective Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina and Texas
- Medical device recall Orthopedic Salvage System (OSS) Hybrid Poly Tibia Cleaning processes potentially being ineffective Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina and Texas
- Medical device recall Orthopedic Salvage System (OSS) Hybrid Poly Tibia Cleaning processes potentially being ineffective Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina and Texas
- Medical device recall Orthopedic Salvage System (OSS) Hybrid Poly Tibia Cleaning processes potentially being ineffective Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina and Texas
- Medical device recall Orthopedic Salvage System (OSS) Hybrid Poly Tibia Cleaning processes potentially being ineffective Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, South Carolina and Texas
- Medical device recall VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot… Lack of package integrity may compromise sterility Class IIFDA’s classAug 21, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereFlorida, Maine, Minnesota, New York, Ohio, Oklahoma and Wisconsin
- Medical device recall K-Wire HBS Sterile Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire Sterile Single Trochar Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire Sterile Single Trochar .045 Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire Single Trocar 2.5x170mm Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire Single Trocar 1.6x150mm Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire Single Trocar 1.1x150mm Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas named
- Medical device recall K-Wire Single Trocar 2.5x150mm Manufacturing flaw in the sterile barrier system Class IIFDA’s classAug 21, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 21, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Maryland, North Carolina, New York, Oregon and Texas 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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