Medical devices, 2016
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3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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 5, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body… A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereArkansas, Indiana, Louisiana, Massachusetts, Minnesota, Oregon and Tennessee
- Medical device recall Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the… A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereArkansas, Indiana, Louisiana, Massachusetts, Minnesota, Oregon and Tennessee
- Medical device recall Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used… A product issues happens for RF projection images. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named
- Medical device recall Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack… Medline Industries, Inc. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Dakota, New Mexico, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2)… Medline Industries, Inc. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Dakota, New Mexico, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog… Medline Industries, Inc. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Georgia, Hawaii, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, North Dakota, New Mexico, Ohio, Oregon, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior… A size 4 Empowr baseplate was mislabeled as a size 6. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Illinois and Indiana named
- Medical device recall TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL DeRoyal received complaints of mold on Tennis Elbow Straps. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL DeRoyal received complaints of mold on Tennis Elbow Straps. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Peripherally Inserted Central Catheters (PICC), UPN H965750141 There is a potential for stylet stiffening that is not accurately represented on the labeling. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Louisiana, Michigan, Minnesota, Missouri, Nevada, Ohio and Texas named
- Medical device recall Peripherally Inserted Central Catheters (PICC), UPN H965750191 There is a potential for stylet stiffening that is not accurately represented on the labeling. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Louisiana, Michigan, Minnesota, Missouri, Nevada, Ohio and Texas named
- Medical device recall Perceval Sutureless Aortic Heart Valve size S Sorin Group USA, Inc. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml The firm received complaints claiming the dental material failed to set up. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml The firm received complaints claiming the dental material failed to set up. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml The firm received complaints claiming the dental material failed to set up. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for… An error may occur with the display of dose computed on images other than the planning CT (auxiliary CT) when using multiple patient cases in RayStation 5. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas and Washington named
- Medical device recall RayStation 4.0, 4.5, 4.7 and 5.0 Software anomaly; an issue was found with the proton Pencil Beam Scanning (PBS) dose calculation in RayStation 4.0, 4.5, 4.7 and 5.0. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Louisiana, Michigan, New Jersey, Tennessee, Texas and Washington named
- Medical device recall Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by… Shipping error. Class IIIFDA’s classDec 14, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 14, 2016ClassClass IIIStatusTerminatedWhereKansas and Virginia
- Medical device recall ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. Siemens is investigating an issue which may cause an incorrect result to be reported. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Michigan, New Jersey, New York, Ohio, Puerto Rico, Texas, Washington, Wisconsin and Wyoming
- Medical device recall Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile) Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access… Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Illinois, Kansas, Minnesota, Missouri, Nebraska, New Jersey, Ohio, Tennessee, Virginia, Wisconsin and Wyoming named
- Medical device recall Magnesium on RX Imola analyser IVD According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge PACS software Cut lines on the image may present horizontally rather than vertically. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AMD-Ritmed Transparent Dressing - Window with label, 4 “ x 4 3/4” The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis. Class IIFDA’s classDec 14, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 14, 2016ClassClass IIStatusTerminatedWhereMassachusetts, New York, Tennessee and Virginia
- Medical device recall Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491… On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 7, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 7, 2016ClassClass IStatusTerminatedWhereCalifornia, Indiana, Kansas, North Carolina, New Jersey, Tennessee, Texas and Utah
- Medical device recall ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereColorado and Nevada
- Medical device recall Monaco RTP System Incorrect Dose when using the reset function. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Turbo Elite Atherectomy Catheter Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ELCA Coronary Atherectomy Catheter Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Bridge Occlusion Balloon Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Merge FlexConnect software, a component of Merge LIS Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Hemo software The application may crash during the cath lab procedure. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hamilton-MR1 Ventilator Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms Firm received reports about “acquisition errors” and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for… Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement Report33 statesnamed in where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall MISAGO RX Self Expanding Peripheral Stem During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall V6 Rear Case Assembly A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system… Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall Adiprep Adipose Transfer System Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the… Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROW OnControl Bone Marrow Biopsy System Tray, Sterile Sterility: Due to a potential incomplete seal on the outer sterile package. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow… Sterility: Due to a potential incomplete seal on the outer sterile package. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROW OnControl Bone Lesion Biopsy System Tray, Sterile Sterility: Due to a potential incomplete seal on the outer sterile package. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OnControl Biopsy System Ported Needle Tray, Sterile Sterility: Due to a potential incomplete seal on the outer sterile package. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROW OnControl Ported Aspiration System Tray, Sterile Sterility: Due to a potential incomplete seal on the outer sterile package. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ST¿CKERT HeaterCooler System 3T On August 1, 2014 Sorin Group USA, Inc. Class IIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Lineage Liners Revision rate trends from within the MicroPort Orthopedics Inc. Class IIIFDA’s classDec 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 7, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Georgia 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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