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 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 classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) ADMIT 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) 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) CHEST/BREAST-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) NEURO SHUNT- CODMAN 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) OB 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) ROBOTIC GYN CDS-1 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 UROLOGY SLING 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) C-SECTION 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) HYSTEROSCOPY 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) 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 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 OPHTHALMIC RUPTURE GLOBE 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) SPINAL 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) ARTHROSCOPY 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 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 classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS 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 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 classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Prodisc Product Name: Prodisc C SK Products were mislabeled as the 6mm product but included the 5 mm product. Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee and Texas named
- Medical device recall MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target… Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or… Class IIFDA’s classFeb 25, 2026in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 25, 2026ClassClass IIStatusOngoingWhereLouisiana, Massachusetts, New York, Pennsylvania, Texas and Virginia
- Medical device recall Medline 14 Fr Suction Catheter Kits A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Intubation Tray (Adult) containing Suction Catheter Kits A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brevera Breast Biopsy System Disposable 9 Gauge Needle Presence of particulates in affected devices that can be deposited into breast tissue during use. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brilliance iCT As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington and West Virginia named
- Medical device recall IQon Spectral CT As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington and West Virginia named
- Medical device recall Spectral CT; Product Code (REF): 728333 As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington and West Virginia named
- Medical device recall Spectral CT 7500 on Rails As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington and West Virginia named
- Medical device recall Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID… These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10… These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology… These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed St These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH… These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco… These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on… These lots of reprocessed catheters may contain small particles of residual material. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1) UNIVERSAL KIT, Kit Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may… Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WB Impression Post Closed Tray incl The mix up of the impression caps provided in the package. Class IIIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Halyard TRANSPORT BAG KIT Tyvek bag seal issue which may compromise sterility of the kit. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1… Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. Class IIFDA’s classFeb 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedFeb 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia 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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