Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Amicus Exchange Kit Therapeutics Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Power-PRO 2 Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and New York and Virginia named
- Medical device recall Access Immunoassay Systems An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement… Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC)… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2)… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall TEMA Axle Small Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 22, 2023ClassClass IIStatusOngoingWhereTexas
- Medical device recall Patient Side Cart Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at… Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Florida, Georgia and Washington named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801 An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801 An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 15, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, 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, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Cardiosave Rescue An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedMar 15, 2023ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, 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, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Simplexa COVID-19 Direct Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Simplexa Flu A/B & RSV Direct Gen II Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Sprint 200 wheeled stretcher Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement Report14 statesnamed in where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereAlabama, California, Florida, Iowa, Kentucky, Louisiana, Minnesota, North Carolina, Nevada, Oklahoma, Texas, Virginia, Washington and West Virginia
- Medical device recall LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the… Users received sample collection kits that were assigned to another user. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama named
- Medical device recall Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China… pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host,… pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Under specific circumstances, the U.S. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM… Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereArkansas, Arizona, California, Nebraska, New Jersey, Pennsylvania, Texas and Wisconsin
- Medical device recall CardioMEMS HF System Patient Electronics System (PES) Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioMEMS HF System Patient Electronics System (PES) Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioMEMS HF System Patient Electronics System (PES) Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioMEMS HF System Hospital Electronics System (HES) Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioMEMS HF System PA Sensor and Delivery System Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioMEMS HF System PA Sensor and Delivery System Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CardioMEMS HF System PA Sensor and Delivery System Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 Product is labeled with an incorrect expiration date. Class IIIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 15, 2023ClassClass IIIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated… New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting… Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio and Washington named
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Hybrid Intra-Aortic Balloon Pump Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Monaco RTP System Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Device was shipped without having regulatory approval. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMar 15, 2023ClassClass IIStatusOngoingWhereMassachusetts
- Medical device recall Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2 When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereFlorida, Iowa, Illinois, Indiana, North Carolina, New Mexico and New York
- Medical device recall CD5 Series of Genesis Reusable Rigid Sterilization Container Systems Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Life2000 Ventilator System, a) There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Life2000 Ventilator PKG, Hospital, a) There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Life2000 Ventilator PKG, Hospital, a) There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall Life2000 Ventilator There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IStatusOngoingWhereNationwide
- Medical device recall ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM Stryker has identified an issue that impacts two specific lots of CLAW” II plates. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM Stryker has identified an issue that impacts two specific lots of CLAW” II plates. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall Summit Medical Nasal Septal Button, Medium, 5cm Sterile product pouches were not sealed. Class IIFDA’s classMar 8, 2023in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 8, 2023ClassClass IIStatusTerminatedWhereColorado, Florida, Georgia, Louisiana, Massachusetts and Maine
- Medical device recall Dermalon Monofilament Nylon Suture Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact Class IIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 8, 2023ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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