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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter 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 Cook¿ Strange Bile Duct Stone Exploration 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 Melker Universal Cuffed Emergency Cricothyrotomy Catheter 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 Multipurpose Drainage Catheter: 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 NCompass¿ Nitinol Stone Extractor: 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 Spectrum¿ Central Venous Catheter 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 Spectrum¿ Central Venous 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 Thal-Quick Chest Tube 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 Wayne Pneumothorax 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 Wayne Pneumothorax 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 Multi-parameter Command Module Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve… Class IIFDA’s classApr 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedApr 15, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Idaho, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Washington, Wisconsin and Wyoming named
- Medical device recall MicroScan Neg Multidrug Resistant MIC 1 Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. 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 B¿R¿A¿H¿M¿S KRYPTOR compact REACT Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting… Class IIFDA’s classApr 15, 2026in FDA’s Enforcement Report11 statesnamed in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Minnesota, North Carolina, New York, Ohio, Texas and Utah
- Medical device recall Stryker Sustainability Solution Color Cuff 24” (Yellow) Quick Connect Dual Port Single Bladder Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. Class IIFDA’s classApr 15, 2026in FDA’s Enforcement Report41 statesnamed in where it went PublishedApr 15, 2026ClassClass IIStatusOngoingWhereAlabama, 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 Hampshire, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Washington
- Medical device recall Purge Cassette Increased risk of purge leaks with Generation 1 purge cassettes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 8, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall Automated Impella Controller (AIC), labeled as the following with corresponding Potential that the “Purge System Blocked” alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 8, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall Blue Ventilator Adapter Module, single-patient use circuit Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 8, 2026ClassClass IStatusOngoingWhereFlorida
- Medical device recall Philips Respironics Trilogy Evo, Software Version 1.05.15.00 In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 8, 2026ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00 In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 8, 2026ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Philips Respironics Trilogy EV300, Software Version 1.05.15.00 In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 8, 2026ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00 In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 8, 2026ClassClass IStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas and Virginia named
- Medical device recall Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas and Virginia named
- Medical device recall RefleXion X1 Radiotherapy System Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereCalifornia, Connecticut, Louisiana, New Jersey, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall Atellica CH Enzymatic Hemoglobin A1c (A1c_E) A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Kiestra” ReadA In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereKansas, Maryland, Minnesota, New Jersey, Texas and Virginia
- Medical device recall Allura Xper FD10C Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD10F Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD10 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD10/10 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD20 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD20 Biplane Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD20 OR Table Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD20 Biplane OR Table Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ALLURA Xper FD10 OR Table Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/10 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/20 OR Table Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Allura Xper FD20/15 OR Table Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M12 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 3 M15 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B12 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 B20 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M12 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M20 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M12 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 5 M20 Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 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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