Medical devices, 2016
Shortlist up to four to read them side by side.
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 6, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Aptio Automation Modules Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FlexLab Automation Modules Recalled by FDA on Nov 23, 2016 Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arsenal Spinal Fixation System, Set Screw Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT Computed Tomography X-ray system The product label does not include the correct current rating. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlabama, Arizona, Colorado, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Utah
- Medical device recall Brilliance ICT SP Computed Tomography X-ray system The product label does not include the correct current rating. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlabama, Arizona, Colorado, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Utah
- Medical device recall Ingenuity CT Computed Tomography X-ray system The product label does not include the correct current rating. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlabama, Arizona, Colorado, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Utah
- Medical device recall Ingenuity Core 128 Computed Tomography X-ray system The product label does not include the correct current rating. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlabama, Arizona, Colorado, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Utah
- Medical device recall Ingenuity Core Computed Tomography X-ray system The product label does not include the correct current rating. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlabama, Arizona, Colorado, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Utah
- Medical device recall IQon Spectral CT Computed Tomography X-ray system The product label does not include the correct current rating. Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlabama, Arizona, Colorado, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Utah
- Medical device recall Merge PACS software The software did not show unviewed images when the last view was skipped. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas and Utah named
- Medical device recall Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography… The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated… The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography… The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are… A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are… A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46)… Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge,… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Michigan, North Dakota, Nebraska and New York named
- Medical device recall SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project… Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge,… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Michigan, North Dakota, Nebraska and New York named
- Medical device recall SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project… Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge,… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Michigan, North Dakota, Nebraska and New York named
- Medical device recall Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as “7.0 x 110mm LTTHCS Screws were identified as having the incorrect part number and lot number marked upon them. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, New Jersey, Ohio and Wisconsin
- Medical device recall OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now… Incorrect lot number on outer kit Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereMaryland, Oklahoma and Texas
- Medical device recall iConnect Access software Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur CA 19-9 Assay CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur CA 19-9 Assay CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of… Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign… Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device… Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall X-Celerator Hydrophilic Exchange Guidewire Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall FindrWIRZ Guidewire System A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 16, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedNov 16, 2016ClassClass IStatusTerminatedWhereArizona, California, Connecticut, Georgia, Illinois, Kansas, Maryland, Michigan, Missouri, Nebraska, New Hampshire, New York, Oregon, Pennsylvania and Texas
- Medical device recall Symbiq One Channel Infuser May go to a white screen due to a problem with the SOM2 module. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Symbiq Two Channel Infuser May go to a white screen due to a problem with the SOM2 module. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm Contract manufacturer packaged an incorrect sheath with the product. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereCalifornia, Kansas, Missouri, New York, Virginia and Washington
- Medical device recall Covidien Devon Light Glove Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile,… Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Added Instructions for Use: After application, inspect the Light Glove for barrier integrity Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer¿ Air Dermatome II Handpiece Loaner Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discoloring after… Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone… The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some… Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Illinois, Maryland, Minnesota, North Carolina, New York and Wisconsin named
- Medical device recall GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE Potential presence of particulate matter on the blood side of the dialyzer Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The surgical table is a stand alone unit The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were manufactured with the incorrect “O” ring which may cause the… Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Iowa, Indiana, Michigan, Minnesota, Missouri, Ohio, Pennsylvania and Virginia named
- Medical device recall Replacement floor locking cylinders for the Schaerer The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Iowa, Indiana, Michigan, Minnesota, Missouri, Ohio, Pennsylvania and Virginia named
- Medical device recall SOMATOM Definition AS system, x-ray, tomography, computed Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition Flash system, x-ray, tomography, computed Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the… There is a potential for a component failure of the device which could necessitate medical intervention. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic… Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in… Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21). Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters The EP Catheters may be mislabeled for French size during reprocessing. Class IIFDA’s classNov 16, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereArizona, Minnesota and Missouri
- Medical device recall Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The… cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002:… Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long Class IIFDA’s classNov 16, 2016in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedNov 16, 2016ClassClass IIStatusTerminatedWhereMassachusetts
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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