Medical devices, 2022: every recall, from FDA

Medical device recall The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode… Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall KWIK-STIK, Candida parapsilosis derived from ATCC 22019 Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7. Class IIIFDA’s classFeb 9, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 9, 2022ClassClass IIIStatusTerminatedWhereGeorgia, Mississippi, Montana, North Carolina, New Mexico, Nevada, Tennessee, Texas, Washington and Wisconsin

Medical device recall KWIK-STIK, Enterobacter cloacae subsp Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10. Class IIIFDA’s classFeb 9, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 9, 2022ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Hawaii, Michigan, North Carolina, New Hampshire, New Jersey, Oklahoma, Oregon and Tennessee

Medical device recall CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen… The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99%… Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named

Medical device recall KWIK-STI(TM), GBS QC Set (Live Culture) The expiration date on the label of one component (negative control 0243U) in the set lot is incorrectly labeled. Class IIIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 9, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Illinois, Maryland, Missouri, Mississippi, New Mexico, Ohio, Oregon, Pennsylvania, Texas and Vermont named

Medical device recall ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B Due to a calculation error in the measurement when using 2D trace (manual trace) tool. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall INTEGRA SURFIX ALPHA Screwdriver Torx 10 The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNationwide, and California and Ohio named

Medical device recall eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version… eCareManager (eCM) Sentry Score software not approved for use Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall OXY-1 System The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on… FDA Class I, its most serious class Class IFDA’s classFeb 9, 2022in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 9, 2022ClassClass IStatusTerminatedWhereFlorida, Georgia, Indiana, Maryland, North Carolina, Pennsylvania and Texas

Medical device recall Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients… Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Massachusetts, New Jersey, Pennsylvania, South Carolina, Texas and Wisconsin named

Medical device recall Premier Rotaclone Product stored incorrectly in temperature controlled setting instead of refrigeration. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and California and Massachusetts named

Medical device recall ARIES HSV 1&2 Assay Impacted lot may leak inside the ARIES instrument. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington and Wisconsin named

Medical device recall HARDY DIAGNOSTICS CatScreen, 25dsk/vial Product stored incorrectly in temperature controlled setting instead of refrigeration. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and California named

Medical device recall YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNo state named

Medical device recall The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue… Certain lots may not have been packaged wth the Channel Tube Limiter. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNationwide, and Georgia named

Medical device recall Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm… The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive… Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Celltrion DiaTrust COVID-19 Ag Rapid Test The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide, and California named

Medical device recall Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides… Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. FDA Class I, its most serious class Class IFDA’s classFeb 2, 2022in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 2, 2022ClassClass IStatusOngoingWhereArkansas, Colorado, Florida, Iowa, Illinois, Kentucky, Louisiana, Michigan, Montana, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming

Medical device recall Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator… Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. FDA Class I, its most serious class Class IFDA’s classFeb 2, 2022in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 2, 2022ClassClass IStatusOngoingWhereArkansas, Colorado, Florida, Iowa, Illinois, Kentucky, Louisiana, Michigan, Montana, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming

Medical device recall Artis pheno with software VE20C- diagnostic imaging angiography system Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Artis icono biplane with software VE20C-diagnostic imaging angiography system Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Artis icono floor with software VE20C-diagnostic imaging angiography system Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Vscan Extend, being The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal… Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement Report50 statesnamed in where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall API ID 32 C Strips, Reference 32200 Risk of misidentification or delayed results with the absence of identification due to thermoforming defect. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereArizona, Iowa, Kentucky and New York

Medical device recall 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in… Friction rubber block in the clamping mechanism was missing in the Footrest. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 2, 2022ClassClass IIStatusOngoingWhereIowa, Kentucky, Louisiana, Massachusetts, North Carolina, New York, Ohio, South Carolina, Washington and West Virginia

Medical device recall PIVO Blood Collection Device 20G Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Illinois, Michigan, North Carolina, New Jersey, Pennsylvania, Utah and Washington named

Medical device recall MAGEC 1 System Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 2, 2022ClassClass IIStatusOngoingWhereNo state named

Medical device recall 8mm FlexDex Needle Driver The firm is reinforcing the IFU instructions: “Do not use if the package is damaged.” If upon inspection of the packaging, any damage is observed, including… Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Medtronic HawkOne Directional Atherectomy System Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. FDA Class I, its most serious class Class IFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 26, 2022ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Senior Living Arial Emergency and Nurse Call Systems Systems are not alarming due to increased memory consumption. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide, and Florida, Maryland, Michigan, Minnesota, South Dakota, Tennessee and Washington named

Medical device recall ARIES HSV 1&2 Assay Impacted lot may leak inside the ARIES instrument. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named

Medical device recall 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI:… Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients,… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Florida, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington and West Virginia named

Medical device recall ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical… lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Draeger Fabius MRI Anesthesia Machine 26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and New York, Pennsylvania and Wisconsin named

Medical device recall greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24… Some of the blood collection tubes show clotting due to variation of Lithium Heparin. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereFlorida, Illinois, Missouri, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas and Virginia

Medical device recall VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS¿ Immunodiagnostic Products High Sample Diluent A… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named

Medical device recall Gentueri Viral Transport Medium (VTM), Sterile, IVD Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and Indiana named

Medical device recall Infa-Therm Transport Mattress, Reference Number 989805616831 1015 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Infant Heel Warmers w/strap, Reference # 989805603201 1223 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide

Medical device recall Heel Snuggler, Reference # 989805603411 99047 After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide

Medical devices, 2022

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