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 See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) C-SECTION PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) HYSTEROSCOPY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See RES for complete list Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DRAPE PACK Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 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 classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) KIT UROLOGY SLING Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ARTHROSCOPY CDS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall See complete list in RES, exceeds character limit Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BioCera Fibers, Bioresorbable Bone Void Filler Resorbable bone void filler falls outside standard specifications. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Florida named
- Medical device recall ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z Resorbable bone void filler falls outside standard specifications. Class IIFDA’s classMay 13, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 13, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Florida named
- Medical device recall Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy)… Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE” family of pacemakers and cardiac resynchronization therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1 Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE” family of pacemakers and cardiac resynchronization therapy… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor… Cyber vulnerability of BLE communication was found by CISA VDP program. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 6, 2026in FDA’s Enforcement ReportKansasthe one state its words name PublishedMay 6, 2026ClassClass IStatusOngoingWhereKansas
- Medical device recall WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable… Cyber vulnerability of BLE communication was found by CISA VDP program. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 6, 2026in FDA’s Enforcement ReportKansasthe one state its words name PublishedMay 6, 2026ClassClass IStatusOngoingWhereKansas
- Medical device recall Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style Product does not have FDA clearance. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VACUUM BAG SU LARGE, Non-sterile specimen container There is a possibility of reagent leakage from the specimen container. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Due to complaints of device breakage at the traction force gauge to handle joint. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty… Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 6, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 6, 2026ClassClass IStatusOngoingWhereCalifornia and Washington
- Medical device recall Medtronic Sphere-9 Catheter Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Genius” Review Station Product Name: Genius” Review Station Display (Barco Monitor) It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: HiResolution” Bionic Ear System Product Name: M Zn-Air Battery Pak The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 Philips Achieva 1.5T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Achieva 3.0T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia 1.5T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia 1.5T CX with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia 3.0T with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia 3.0T CX with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia Ambition S with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia Ambition X with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Ingenia Elition S with MR Elastography (MRE). 1 The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant’s algorithm, leading… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 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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