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 Lima 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 Skin and Vein 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 Vasc Custom 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 Bariatric 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 Neck 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 Abdominal Pack and Abdom 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 Stradi 4500 - 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 Gyn 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 Head & Neck 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 Eye 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 Glaucoma 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 Shoulder 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 Knee Arthro Pack and Knee Arthro Pack II - 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 ENT 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
- Medical device recall Podiatry 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 Minor Pack and Minor Pack II 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 Neurosurgery 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 Cysto 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 Open 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 Pediatric 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 Set Up 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 Blepharoplasty 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 Custom 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 DND 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 Orthopedic Split Drape 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 Arthroscopy 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 Upper Extremity 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 Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano’s sS/Si, Core, and ComboMap systems. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano’s sS/Si, Core, and ComboMap systems. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ComboMap Intravascular Flow and Pressure System A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano’s sS/Si, Core, and ComboMap systems. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation… The thread location on one of the thread holes is offset from the axis of the predrill hole. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, Florida, Georgia, Massachusetts, Maryland, North Carolina, New Jersey, Pennsylvania and Texas
- Medical device recall PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The… Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The… Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with… Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC… Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereMissouri and South Carolina
- Medical device recall Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for… 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar,… Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System… Two software issues may occur in Vista software version 3.6.1. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus)… Mislabeling. Class IIIFDA’s classJul 15, 2015in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJul 15, 2015ClassClass IIIStatusTerminatedWhereVirginia
- Medical device recall Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch Integra LifeSciences Corp. Class IIFDA’s classJul 15, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Navigated Cannulated Taps Individual cannulated taps are Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number… SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in… Class IIFDA’s classJul 8, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereFlorida and Tennessee
- Medical device recall The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used… After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Catheters may not meet antimicrobial specification Class IIFDA’s classJul 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2015ClassClass IIStatusTerminatedWhereNationwide
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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