Medical devices, 2020: every recall, from FDA

Medical device recall Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within… May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire Class IIFDA’s classJan 22, 2020in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Massachusetts, Michigan, North Carolina, Ohio and Wisconsin

Medical device recall Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet) The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named

Medical device recall Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6.… Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly. Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either Monitor/Defibrillator may not deliver a shock after the “Shock” button on the keypad is pressed as a result of oxidation that has formed over time within the… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide, 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits Monitor/Defibrillator may not deliver a shock after the “Shock” button on the keypad is pressed as a result of oxidation that has formed over time within the… Class IIFDA’s classJan 22, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJan 22, 2020ClassClass IIStatusTerminatedWhereNationwide, 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall LightPod ERA lasers This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall LightPod Neo Lasers This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Idaho, Illinois, Kentucky, New Jersey, Ohio, South Carolina and Texas named

Medical device recall Stratum MDS Screw 3.5x46mm ST Components 2mm shorter than indicated on the package label Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Stratum MDS Screw 3.5x48mm ST Components 2mm shorter than indicated on the package label Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Stratum MDS Screw 3.5x50mm ST Components 2mm shorter than indicated on the package label Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence… The kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement Report21 statesnamed in where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Washington

Medical device recall Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to… Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Pin To Rod Coupling could not clamp the pin and rod as intended Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Michigan, North Carolina, New Jersey, Texas and Washington named

Medical device recall Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical… During a routine inspection of a system, a crack on the C-arm holder was discovered. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Illinois, Michigan, Nebraska, Nevada, New York, Pennsylvania, Puerto Rico and Texas named

Medical device recall Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1 Avanos Medical has received reports stating that the central lumen of some 5 Fr Neonate/Pediatric Closed Suction Catheters may be fully blocked or partially… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Florida, Iowa, Massachusetts, Michigan, Mississippi, New Hampshire, New York, Ohio, Pennsylvania, Utah, Virginia and Wisconsin named

Medical device recall ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx The peek part was loose on the titanium base of the device which could result in it falling into a patient’s mouth during a procedure resulting in aspiration… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement Report26 statesnamed in where it went PublishedJan 15, 2020ClassClass IIStatusCompletedWhereAlabama, Arizona, California, Florida, Georgia, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia

Medical device recall ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx The peek part was loose on the titanium base of the device which could result in it falling into a patient’s mouth during a procedure resulting in aspiration… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement Report26 statesnamed in where it went PublishedJan 15, 2020ClassClass IIStatusCompletedWhereAlabama, Arizona, California, Florida, Georgia, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia

Medical device recall Cochlear Baha 5 Sound Processor Tamper Proof Battery Door Product was packaged with the Incorrect tamper proof battery door. Class IIFDA’s classJan 15, 2020in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 15, 2020ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Indiana, Massachusetts, Missouri, New York, South Dakota, Tennessee and Texas

Medical device recall Clearlink System Continu-Flo Administration Sets Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall ONE-LINK Needle-free IV Connector Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection… Class IIFDA’s classJan 15, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall The products involved are DeWALT laser distance measurers The products are labeled as Class II lasers. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall HeartMate 3 Mobile Power Unit Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular… Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Blood Glucose Monitoring System Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medicrea Pass LP It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida, New York, Ohio, Pennsylvania and Texas

Medical device recall i-STAT cTnI cartridge i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement Report34 statesnamed in where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming

Medical device recall iMRX MRI and Angiography System There is a potential hardware error for the iMRX System with a generator A100. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereConnecticut, Massachusetts and Virginia

Medical device recall Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine… An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named

Medical device recall Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled… An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named

Medical device recall Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray… An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named

Medical device recall Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment… An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedJan 8, 2020ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas and Utah named

Medical device recall O-arm” O2 Imaging System, Product Number/CFN: BI-700-02000 Due to a manufacturing issue affecting particular O-arm” O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over… Class IIFDA’s classJan 8, 2020in FDA’s Enforcement Report27 statesnamed in where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Virginia, Washington, Wisconsin and West Virginia

Medical device recall The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT… Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting… Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Michigan, New York, Ohio, Pennsylvania and Texas named

Medical device recall NIDEK Specular Microscope The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) Class IIIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJan 8, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Illinois, Kansas, Maryland, New Jersey, New York, Pennsylvania, South Carolina and Virginia named

Medical device recall There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron… A component failure may lead to treatment interruption or incorrect source positioning. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Invia Foam Dressing Kit with FitPad - X-Large Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. Class IIFDA’s classJan 8, 2020in FDA’s Enforcement Report16 statesnamed in where it went PublishedJan 8, 2020ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Minnesota, Missouri, North Carolina, New York, Pennsylvania, South Carolina, Tennessee, Texas and Washington

Medical devices, 2020

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