Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Avenir Muller Stem A potential commingle that could result in the product in the package not matching the product on the outer label. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Avenir Muller Stem A potential commingle that could result in the product in the package not matching the product on the outer label. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Hinge Coupling Hoffmann LRF The wrong parts were picked for packaging. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EEA” Hemorrhoid and Prolapse Stapler Set with DST Series” Technology 3.5MM, Product Number HEM3335, GTIN… There is a potential for improper welding of the yellow staple guide to the instrument. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall EEA” Hemorrhoid and Prolapse Stapler Set with DST Series” Technology 4.8MM, Product Number HEM3348, GTIN… There is a potential for improper welding of the yellow staple guide to the instrument. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah and Virginia named
- Medical device recall Accelerate PhenoTest BC kit The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Illinois, South Carolina and Texas
- Medical device recall CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit… Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342) Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3) Products labeled for distribution outside the United States may have been distributed to customers in the United States. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report27 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Washington, Wisconsin and West Virginia
- Medical device recall Widefield OCT software feature for the Spectralis HRA+OCT and variants FDA notified Heidelberg Engineering that a 510(k) clearance is needed for the SPECTRALIS Widefield OCT feature, and, on November 27, 2017, Heidelberg… Class IIFDA’s classMay 2, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. Class IIFDA’s classMay 2, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 2, 2018ClassClass IIStatusTerminatedWhereArizona, Maine, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee and Vermont
- Medical device recall Fornier Phantom Fiber(TM) Sutures Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020 Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall MINC Benchtop Incubator (Mini Incubator) The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MINC Benchtop Incubator (Mini Incubator) The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector… There is potential for a cart with disinfected goods to unload without the trolley being docked. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109,… There is potential for a cart with disinfected goods to unload without the trolley being docked. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Segmental System Proximal Femoral Component 38mm Offset There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Infinity Acute Care System (IACS) Monitoring Solution The invasive pressure visual and audible alarms may not activate. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and… The U.S. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and… The U.S. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories… The U.S. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOUTHERN IMPLANTS The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Human Fetal Hemoglobin (HBF-1) FITC Conjugate Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oregon, Pennsylvania, South Carolina, Texas and Washington
- Medical device recall Power-LOAD Cot Fastening System The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive… NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager)… While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ingenuity TF PET/CT Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Ohio and Oregon named
- Medical device recall GE Healthcare Lunar: a) DPX Duo Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare Lunar: a) DPX NT Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare: a) Prodigy Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Brilliance 64 with 4.1.7 XX026 software version Surview scan with tube current lower than 30 mA is unable to be initialized. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Georgia, Michigan and Virginia named
- Medical device recall MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall ONCOR Avant-garde, Digital Linear Accelerator Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall ONCOR Expression, Digital Linear Accelerator Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall ONCOR Impression , Digital Linear Accelerator Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall ONCOR Impression Plus, Digital Linear Accelerator Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall PRIMUS HI, Digital Linear Accelerator Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Wisconsin, West Virginia and Wyoming named
- Medical device recall Teleflex MEDICAL HUDSON RCI One Way Valve w These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the… Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Flex Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity CT Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Core Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Core 128 Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. Class IIFDA’s classApr 25, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 25, 2018ClassClass 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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