Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Olympus High Flow Insufflation Unit Issue with software algorithm which may lead to overpressure events. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Teslatome Bipolar Sphincterotomes Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current… Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereCalifornia, Colorado, Indiana and North Carolina
- Medical device recall MediHoney Gel with Active Leptospermum Honey Potential packaging failures, which could lead to a breach in the sterile barrier. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY Potential packaging failures, which could lead to a breach in the sterile barrier. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Private Label CVS Potential packaging failures, which could lead to a breach in the sterile barrier. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Michigan, Missouri, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and… Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 Due to damage to outer tray that can potentially compromise the sterile barrier Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and 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, Nebraska, 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 and West Virginia named
- Medical device recall Brand Name: Spectrum IQ Product Name: Infusion Pump Pumps were released without full testing being performed, including occlusion alarm testing. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportOhiothe one state its words name PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereOhio
- Medical device recall Estrone RIA, REF: DSL8700 The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and North Carolina named
- Medical device recall Medica Capillary Tubes A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when… Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5 mm, 45 cm Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Thunderbeat 5 mm, 10 cm, Inline Grip Firm is initiating a removal due to continued reports of adverse events. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MONARCH Platform, Bronchoscopy Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope… Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Medline Convenience Kits: 1) ANCILLARY PACK-LF Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) SCC RF PAIN MGMT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ENDO KIT W/SYRINGE Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) OR ARTERIOGRAM Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) OPEN HEART CDS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PICC LINE TRAY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DENTAL PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) LITHOTOMY PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT ACES INSERT PEG Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) LVAD DRIVELINE TRAY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) WMC I D PACK-LF Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) BURN PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT GENERAL CLOSURE Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DRAPE PACK-CHOICE Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PPE KIT Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass 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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