Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations… Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations… Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations… Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations… Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of… Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800 The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, New Jersey, Nevada, Ohio and Tennessee named
- Medical device recall The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the… Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system Inadequate curing of adhesive, may cause the two halves of the spheres to separate. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and… ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Missouri and Wisconsin named
- Medical device recall 16mm Chisel Blade It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Idaho, Indiana, Kansas, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, Ohio, Tennessee, Utah, Virginia, Washington and Wisconsin
- Medical device recall RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5 EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Illinois, New Jersey, New York, Ohio and Texas named
- Medical device recall RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5 EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Illinois, New Jersey, New York, Ohio and Texas named
- Medical device recall RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2 EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Florida, Illinois, New Jersey, New York, Ohio and Texas named
- Medical device recall BD Flow Cytometers Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration’s (FDA’s) Guidance on Laser… Class IIIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA) The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care Unintended treatment termination could result from a keypad malfunction in some situations. Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alere i flu, Alere i, Alere Influenza A & B Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit Class IIFDA’s classJul 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJul 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wyoming named
- Medical device recall Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Primus (THE BTE WS30) On the Primus that includes the optional Chop / Lift Bar, there is a remote possibility that the Chop / Lift Bar could get accidently detached from the snap… Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips GoSafe Communicator 7000L Personal emergency response system. Home communicator Model 7000L may not sense the phone line under certain unusual landline phone conditions. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Connecticut, Florida, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Montana, North Carolina, Nebraska, New Hampshire, New York, Ohio, Oregon, South Carolina, Virginia, Washington and Wisconsin named
- Medical device recall Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Missouri, New Jersey and Virginia
- Medical device recall Nakoma-SL Anterior Cervical Plating System’s Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL… Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw… Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Puerto Rico and Texas named
- Medical device recall The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to… Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or… Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Breast Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Basic Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Advanced Vein Care - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains… Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Standard Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall General Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Vein & Vascular Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during… Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Tummy Tuck Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Mississippi Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Face Lift Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Suction Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall ACL Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Hand Pack - contains Devon Light Glove Used during surgery Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJul 15, 2015ClassClass IIStatusCompletedWhereNationwide, and Alaska, Alabama, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Washington 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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