Medical devices: every recall, from FDA

Medical device recall iLet Ace Pump Kit it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named

Medical device recall LinkBio CORE Workstation, a component of the CORE Shoulder System The CORE Workstation may display an incorrect “Planning Date “ when viewing cases on the “Start Case” menu screen. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Florida and Kansas named

Medical device recall Arjo Tenor mobile passive patient lift An internal component of the actuators in a certain production batch may not meet the required mechanical strength. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide

Medical device recall Instinct Plus Endoscopic Clipping Device Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall ARTIS Pheno VE30A and VE40A During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall React Health PHOENIX 5L Oxygen Concentrator Devices which did not meet internal quality specifications were inadvertently distributed. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and New York named

Medical device recall Cytal Wound Matrix 2-Layer 5x5 cm Increased rate of out-of-specification endotoxin results. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Cytal Wound Matrix 2-Layer 7x10 cm Increased rate of out-of-specification endotoxin results. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Cytal Wound Matrix 2-Layer 10x15 cm Increased rate of out-of-specification endotoxin results. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Cytal Burn Matrix 7x10 cm Increased rate of out-of-specification endotoxin results. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Cytal Burn Matrix 10x15 cm Increased rate of out-of-specification endotoxin results. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Maine, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL… Due to a quality issue regarding the presence of burr on the finished cervical plate product. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, New York and Texas named

Medical device recall Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide

Medical device recall Gentuity HF-OCT Imaging System The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx… Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Massachusetts, Minnesota, New Jersey, New York, Ohio, Pennsylvania and Texas named

Medical device recall CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and South Carolina named

Medical device recall Philips Spectral CT on Rails Philips has identified three software issues: 1. Class IIFDA’s classApr 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Minnesota named

Medical device recall ARTIS pheno and ARTIS Icono biplane, floor and ceiling During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNationwide

Medical device recall NAMIC Angiographic Syringe, labeled as follows: 1 Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result… FDA Class I, its most serious class Class IFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall NAMIC Angiographic Control Syringe, labeled as follows: 1 Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result… FDA Class I, its most serious class Class IFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic… Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result… FDA Class I, its most serious class Class IFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall NAMIC Angiographic Syringe, labeled as follows: 1 Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result… FDA Class I, its most serious class Class IFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic… Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result… FDA Class I, its most serious class Class IFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 15, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named

Medical device recall Tornier HRS Max parts: 1 Affected products were incorrectly labeled as Tornier HRS Max products. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall MicroScan Neg MIC 3J Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 15, 2026ClassClass IIStatusOngoingWhereOregon

Medical device recall See Luer Cap Set, MPC-130, set, administration, intravascular Molded Products, Inc. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Illinois, Nevada, Tennessee and Texas named

Medical device recall COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

Medical device recall COOK MEDICAL Cook Staged Extubation Set: Reference Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNo state named

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