Medical devices, 2021: every recall, from FDA

Medical device recall Atec Insignia Anterior Cervical Plate System There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock… Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Hawaii, Idaho, Illinois, Indiana, Massachusetts, North Carolina, New Mexico, New York, Oklahoma, South Carolina, Texas and Washington named

Medical device recall VIA Microcatheter VIA 17 Due to inadvertently shipping to U.S. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Florida, Iowa, Michigan, Minnesota, Tennessee and Texas named

Medical device recall VIA Microcatheter VIA 21 Due to inadvertently shipping to U.S. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Florida, Iowa, Michigan, Minnesota, Tennessee and Texas named

Medical device recall VIA Microcatheter VIA 27 Due to inadvertently shipping to U.S. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Florida, Iowa, Michigan, Minnesota, Tennessee and Texas named

Medical device recall Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information… Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, Nebraska, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, South Carolina, Texas, West Virginia and Wyoming named

Medical device recall DeRoyal Pacemaker Tray Pgybk DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the… FDA Class I, its most serious class Class IFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Louisiana, Mississippi, New York and Virginia named

Medical device recall DeRoyal Heart Cath Procedure Pack DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the… FDA Class I, its most serious class Class IFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Louisiana, Mississippi, New York and Virginia named

Medical device recall DeRoyal Angio Cath Removal Tray DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the… FDA Class I, its most serious class Class IFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 16, 2021ClassClass IStatusTerminatedWhereNationwide, and Louisiana, Mississippi, New York and Virginia named

Medical device recall Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Georgia, Kansas, Massachusetts, Michigan, Minnesota, Mississippi, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin and West Virginia named

Medical device recall ViewRay MRIdian Linac System Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNo state named

Medical device recall SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall RayStation (Treatment Planning System) Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall NICO Myriad-LX Illumination Pack (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the… Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during… (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the… Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A The devices may not meet the minimum required sterility assurance level. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedJun 16, 2021ClassClass IIStatusOngoingWhereWisconsin

Medical device recall Olympus Sterile Optical Laser Fiber, single use and reusable Product sterility is potentially compromised. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Quanta System Sterile Optical Laser Fiber, single use Product sterility is potentially compromised. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Quanta System Sterile Optical Laser Fiber, reusable Product sterility is potentially compromised. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement Report21 statesnamed in where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Maine, Minnesota, Missouri, Montana, North Carolina, Nebraska, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee and Wisconsin

Medical device recall ExacTrac Dynamic software Display of potential patient movement might be delayed to the user for high dose treatments. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Indiana, North Carolina, New Jersey, New York, Oregon, Pennsylvania and Texas named

Medical device recall CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131 The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a package labeled as a Square Electrode. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereCalifornia, Maryland, Missouri, New Jersey, Pennsylvania and Texas

Medical device recall Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution… FDA Class I, its most serious class Class IFDA’s classJun 9, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 9, 2021ClassClass IStatusCompletedWhereFlorida, Georgia, Illinois, New York and Puerto Rico

Medical devices, 2021

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