Medical devices
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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 6, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: CORFLO* Safety PEG Kit Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: CORFLO* Safety PEG Kit Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: CORFLO Safety PEG Kit with ENFit Connector Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SD LTM 64 PLUS, EEG Amplifier/recorder Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida and Pennsylvania named
- Medical device recall DigitalDiagnost C90 Flex/Value/Chest/ER System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 17, 2026ClassClass IIStatusOngoingWhereCalifornia
- Medical device recall NeoSpan¿ SuperElastic Compression Staple w/Instruments Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement Report25 statesnamed in where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall NexxZr T Multi A3.5 W98-16mm Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Idaho, Minnesota, Missouri and New York named
- Medical device recall Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm The cannulation of the CCS screw is not centered. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Louisiana, North Carolina and Texas named
- Medical device recall Brand Name: EXENT Analyser Product Name: EXENT Analyser It was reported that plates 2 and 3 were marked as passed , although it appeared that QC had not been performed on these plates, despite samples being measured. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC) A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Hintermann Series Talar Implant, Left, Size 2 Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California and Idaho named
- Medical device recall Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Missouri and Tennessee named
- Medical device recall Bicarby Dialysate There is an error in the labeling of the GTIN on the product. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportTexasthe one state its words name PublishedJun 17, 2026ClassClass IIStatusOngoingWhereTexas
- Medical device recall Boston Scientific CSK Electrodes Reusable electrodes may not meet expected performance levels. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Boston Scientific TCN Electrodes Reusable electrodes may not meet expected performance levels. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Boston Scientific Sterile anchors my lack sterility assurance. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Louisiana, Maryland, Oklahoma, South Carolina and Utah named
- Medical device recall Merlin” Patient Care System (PCS) software Merlin” PCS 3650 programmer Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, 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 MOSAIQ Oncology Information System Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida, Iowa, Kansas, Louisiana, New Jersey, New Mexico, New York, Texas and Wisconsin named
- Medical device recall Halyard, Pain Pack Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa named
- Medical device recall Halyard, Towel Six Pack Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa named
- Medical device recall Halyard, Drape Pack Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa named
- Medical device recall Halyard, Eye Bag Pack Inadvertent distribution of sealed pouches that had not undergone validated sterilization. Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa named
- Medical device recall Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50 Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence… Class IIFDA’s classJun 17, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. Class IIFDA’s classJun 10, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Atlan A350. Model Number: 8211500. anesthesia workstation The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereArkansas, Arizona, Colorado, Florida, Massachusetts, Minnesota, North Dakota, New York, Pennsylvania, South Dakota and Wisconsin
- Medical device recall Atlan A350XL The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereArkansas, Arizona, Colorado, Florida, Massachusetts, Minnesota, North Dakota, New York, Pennsylvania, South Dakota and Wisconsin
- Medical device recall Pediatric care bed If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall LVP software of the Ivenix Infusion System (IIS) Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Ivenix Infusion System (IIS), Large Volume Pump Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement Report21 statesnamed in where it went PublishedJun 10, 2026ClassClass IStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin
- Medical device recall BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJun 10, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
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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