Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, 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 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5”CS25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5”STER 50 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9” STER25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25” STER25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25 Reports of various packaging issues that may result in a breach of the sterile barrier. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone… Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Indiana, Tennessee and Texas named
- Medical device recall muRata Vios Monitoring System During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker … Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 22, 2025ClassClass IIStatusCompletedWhereNationwide, and Louisiana and New York named
- Medical device recall McKesson Cardiology Hemo software Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Change Healthcare Cardiology Hemo software Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Change Healthcare Cardiology Hemodynamics software Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s). Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall VerifyNow P2Y12 Platelet Reactivity Test Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior… Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide, and Virginia named
- Medical device recall LithoCrushV Single Use Mechanical Lithotriptor V Potential for distal tip tearing of the Mechanical Lithotriptor V. Class IIFDA’s classJan 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VasoView HemoPro 2 Endoscopic Vessel Harvesting System Potential for two issues: 1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System Potential for two issues: 1. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 15, 2025ClassClass IStatusOngoingWhereIdaho, Minnesota, Nevada, Texas, Virginia and Wisconsin
- Medical device recall JMC5A Ni/TruAire-5 Oxygen Concentrator Oxygen concentrator may melt or catch on fire during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 15, 2025in FDA’s Enforcement ReportOhiothe one state its words name PublishedJan 15, 2025ClassClass IStatusOngoingWhereOhio
- Medical device recall Dialyzer Optiflux 160NRe Potential for internal blood leaks due to cracked polyurethane Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VACUETTE SAFELINK The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois and Pennsylvania named
- Medical device recall Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative… Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Smaxel Fractional CO2 Laser, a Class IV medical laser system. The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement… Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. Class IIIFDA’s classJan 15, 2025in FDA’s Enforcement Report15 statesnamed in where it went PublishedJan 15, 2025ClassClass IIIStatusOngoingWhereArkansas, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Missouri, North Carolina, New York, Ohio, Oklahoma, Tennessee, Texas and Virginia
- Medical device recall EnVisio Patient Pad Transition Cushion There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Minnesota, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Carolina and Wisconsin
- Medical device recall 100V NEPTUNE 3 ROVER JAPANESE Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereGeorgia, Illinois and Washington
- Medical device recall Aerin Medical VivAer Stylus Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Xhibit Telemetry Receiver Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report44 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall Xhibit Telemetry Receiver with Software Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report27 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maine, Minnesota, Missouri, Mississippi, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall GE Healthcare Optima XR200amx, Mobile Digital Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Optima XR220amx, Mobile Digital Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Optima XR240amx, Mobile Digital Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column… Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000,… Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AMT Mini Enteral Extension Set, 12” Right Angle Feeding Set with Y-Port The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusCompletedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia and Washington
- Medical device recall Citric Complete - Dry Citric Acid Concentrate The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Illinois, Michigan, North Carolina, New Jersey, Ohio, Tennessee and Texas
- Medical device recall Brand Name: 3B Medical, Inc The devices were inadvertently shipped after their expiration date. Class IIFDA’s classJan 15, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 15, 2025ClassClass IIStatusOngoingWhereArkansas and Massachusetts
- Medical device recall AURYON LASER SYSTEM 100-120 VAC Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SynchroMed II Software issues were identified in application version 2.x. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SynchroMed II Software issues were identified in application version 2.x. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SynchroMed II Software issues were identified in application version 2.x. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SynchroMed II Software issues were identified in application version 2.x. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Devices were identified as released after repair without full testing being performed, which includes flow testing. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama and Indiana named
- Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Devices were identified as released after repair without full testing being performed, which includes flow testing. Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama and Indiana named
- Medical device recall Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin… Class IIFDA’s classJan 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2025ClassClass 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.
Source:
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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