Medical devices, 2020: every recall, from FDA

Medical device recall Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with… Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the… FDA Class I, its most serious class Class IFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IStatusTerminatedWhereNationwide

Medical device recall K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1 The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Kansas, Maryland, Michigan, Missouri, Montana, New York, Oregon and Texas named

Medical device recall AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is… hearing performance degradation due to body-fluid entering the device. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to… hearing performance degradation due to body-fluid entering the device. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall STEALTH SPRING CLIP 6mm latis Failure of cardiovascular clips to provide sufficient occlusion of the vessel. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product… The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. Class IIIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Florida named

Medical device recall Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products,… Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for… Observed an internal repetitive software glitch in ImmersiveView. Class IIIFDA’s classMay 27, 2020in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedMay 27, 2020ClassClass IIIStatusOngoingWhereIllinois

Medical device recall SELECTSILICONE” 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley… Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Illinois, Kentucky, Missouri, New Jersey, Oregon, Tennessee, Texas, Virginia and Washington named

Medical device recall SELECTSILICONE” 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter… Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Illinois, Kentucky, Missouri, New Jersey, Oregon, Tennessee, Texas, Virginia and Washington named

Medical device recall SELECTSILICONE” 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley… Loose silicone particulate was found to be present on the shaft of the silicone catheters. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Illinois, Kentucky, Missouri, New Jersey, Oregon, Tennessee, Texas, Virginia and Washington named

Medical device recall AMS 700 100 mL, Spherical Reservoir with InhibiZone A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Maryland, North Carolina, Nevada and Texas named

Medical device recall BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall B-Hydroxybutyrate LiquiColor Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Kansas and North Carolina named

Medical device recall Professional Urine Drug Control Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Kansas and North Carolina named

Medical device recall Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Kansas and North Carolina named

Medical device recall Conformable Thoracic Stent Graft The incorrect label was placed on both the primary and secondary package. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital… The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium… Potential product mix-up. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida named

Medical device recall Renuvion/ J-Plasma Precise Open Handpiece Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical devices, 2020

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