Medical devices, 2022: every recall, from FDA

Medical device recall MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereConnecticut, New York and Ohio

Medical device recall MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereConnecticut, New York and Ohio

Medical device recall RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with… The outer package is mislabeled and the package contains a different IOL strength. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Indiana, Michigan, Minnesota, Missouri, North Dakota, New Jersey, Oklahoma, Tennessee and Texas named

Medical device recall syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono… After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human… Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Illinois, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, Oklahoma, South Dakota, Tennessee, Texas and Washington named

Medical device recall Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human… Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Illinois, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, Oklahoma, South Dakota, Tennessee, Texas and Washington named

Medical device recall Artis Icono, Interventional Fluoroscopic X-Ray System During system tests, an increased wearing of the Image acquisition system fans has been observed. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement Report32 statesnamed in where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin

Medical device recall Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray… It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Illinois, Louisiana, Maine, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Wisconsin named

Medical device recall Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message:… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor… High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in… Class IIFDA’s classJul 13, 2022in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 13, 2022ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Indiana, Massachusetts, Michigan, North Carolina, New Mexico, New York, Ohio, Pennsylvania and Texas

Medical device recall QMS Tacrolimus Immunoassay Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when… Class IIFDA’s classJul 6, 2022in FDA’s Enforcement Report21 statesnamed in where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereAlabama, Arizona, California, District of Columbia, Florida, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia

Medical device recall Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices Backup batteries can fail earlier than their estimated life. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Field replacement back up batteries Backup batteries can fail earlier than their estimated life. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Medline Pill Splitters Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall #1 MAC F/O LARYNGOSCOPE Packaging error. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall System: Alphenix 4D CT in combination with CAS-930A (C arm Support) CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel… Class IIFDA’s classJul 6, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, New York and Wyoming

Medical device recall Arrow Three-Lumen CVC Gravity flow rates on the affected product lidstock are incorrect. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida named

Medical device recall Stryker INFINITY Resect Guide for INBONE Talus, Size 4 The instrument is incorrectly color coded. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania, Texas and Washington named

Medical device recall ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier Due to interference with the Live Listen feature of hearing aid or AirPods, the user’s iPhone may perform automatic processing of the urination sound signal,… Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Sensica Urine Output System Complaints relating to urine output measurement accuracy. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Artis Pheno, Interventional Fluoroscopic X-Ray System A video signal from one of the transceivers of the Large Display may be lost. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile. A nonsterile component was packaged in a sterile convenience kit. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Florida named

Medical device recall SOLTIVE SuperPulsed Laser Fibers Device model and size for affected lots of Laser Fibers may be mismatched between the product’s carton, immediate pouch packaging, and/or the device. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the… Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereArizona, Illinois, Kansas, Louisiana, Michigan, New York, Ohio, Oklahoma, Texas and Virginia

Medical device recall Product Name: TEG5000 Analyzer When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of… Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall RayStation 11B This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and New Jersey and Texas named

Medical device recall DVR Anatomic One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Maine, Minnesota, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New York, Tennessee, Virginia, Washington and Wisconsin named

Medical device recall Volcano Visions PV. 035 Digital IVUS Catheter Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications Class IIIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 6, 2022ClassClass IIIStatusOngoingWhereNationwide, 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, 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 Optiflux 200NRe Dialyzer Finished Assy. Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm’s standard operating procedure. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named

Medical device recall HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined… The product is not able to provide irrigation. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined… The product is not able to provide irrigation. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall NaviCare Nurse Call/Voalte Nurse Call An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse… Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Yukon Straight Rod 4.0 x120mm Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement Report8 statesnamed in where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereFlorida, Georgia, Nebraska, Nevada, New York, Ohio, Oklahoma and South Carolina

Medical device recall VOLISTA StandOP Surgical Light Paint particles may detach and fall in the operating field. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Georgia, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia and Washington named

Medical device recall Product Name: GCX Channel Mounting Accessory Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory… Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall TEG 5000 Functional Fibrinogen Reagent Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall HeartWare Battery Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer… FDA Class I, its most serious class Class IFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2022ClassClass IStatusOngoingWhereNationwide

Medical device recall Alcon Clareon IOL with AutonoMe Delivery System Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement Report16 statesnamed in where it went PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Michigan, Missouri, New York, Ohio, Oklahoma, Texas, Virginia and Wisconsin

Medical device recall Medfusion Syringe Pump Multiple issues with the potential for interruption of therapy or over-infusion: 1. FDA Class I, its most serious class Class IFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 29, 2022ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named

Medical device recall Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51,… Multiple issues with the potential for interruption of therapy or over-infusion: 1. FDA Class I, its most serious class Class IFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 29, 2022ClassClass IStatusOngoingWhereNationwide, and US Virgin Islands named

Medical device recall REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedJun 29, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Michigan, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Pennsylvania, Tennessee and Washington named

Medical device recall Colonovideoscope A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide, and Kentucky named

Medical device recall EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the… Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 29, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida, North Carolina and New York named

Medical device recall Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire… Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. FDA Class I, its most serious class Class IFDA’s classJun 29, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 29, 2022ClassClass IStatusTerminatedWhereColorado, Florida, Indiana, Missouri, New Jersey and Virginia

Medical device recall Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire… Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. FDA Class I, its most serious class Class IFDA’s classJun 29, 2022in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 29, 2022ClassClass IStatusTerminatedWhereColorado, Florida, Indiana, Missouri, New Jersey and Virginia

Medical device recall Metalogix Slotted 90 Tubular Wrench x 10mm Due to manufacturing processing error, wrench causing stripping when torqueing nuts. Class IIFDA’s classJun 29, 2022in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 29, 2022ClassClass IIStatusOngoingWhereArizona, Connecticut, Georgia, Ohio and Virginia

Medical device recall BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of… Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number:… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 29, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Indiana, Massachusetts, Minnesota, Nevada, South Carolina, Texas and Washington named

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