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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall CinchLock Flex Knotless Anchor with Inserter Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Axial Torque Limiting Driver A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Indiana, Massachusetts, Michigan, Ohio, Pennsylvania, Tennessee, Utah and Virginia named
- Medical device recall Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version… Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one… Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report25 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Covidien Kangaroo Connect Enteral Feeding Pump Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Kangaroo Connect Enteral Feeding Pump Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereConnecticut, Illinois, Nebraska, Puerto Rico and South Carolina
- Medical device recall Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Advia Chemistry Assay: LDL Cholesterol, Direct Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and… Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Advia Chemistry Assay: Lactate Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c)… Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Assays: Direct HDL Cholesterol (AHDL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Assays: ENZYMATIC CREATININE Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Assays: Triglycerides (TGL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Assays: Uric Acid (URCA) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Vista Assays: Direct HDL Cholesterol (AHDL) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Vista Assays: Enzymatic Creatine (ECRE) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Vista Assays: Triglycerides (TRIG) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dimension Vista Assays: Uric Acid (URCA) Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Class IIFDA’s classMay 18, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedMay 18, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Dialog+ Hemodialysis machines: Dialog A + HE/BIC Potential leakage of conductivity sensors of the Dialog Dialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 11, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Potential leakage of conductivity sensors of the Dialog Dialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 11, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Potential leakage of conductivity sensors of the Dialog Dialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 11, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Potential leakage of conductivity sensors of the Dialog Dialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 11, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Potential leakage of conductivity sensors of the Dialog Dialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 11, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for… Potential leakage of conductivity sensors of the Dialog Dialysis machines. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMay 11, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington and Wisconsin named
- Medical device recall Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD” LC/MS/MS… Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system… The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereArizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall MAKOplasty Hip Array Kit Laminate 150230 Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereColorado, Kentucky, Minnesota, Washington and West Virginia
- Medical device recall GE, Revolution CT An out of tolerance torque tool was used on three joints during the manufacturing process. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, North Carolina and Texas
- Medical device recall Pentaray NAV High-Density Mapping Catheter Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pentaray NAV High-Density Mapping ECO Catheter Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE)… While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490 Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide, and New York and Ohio named
- Medical device recall CARESTREAM Image Suite V4 Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide, and New York and Ohio named
- Medical device recall TCM CombiM Modules 903-111 Radiometer America, Inc. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Nevada, New York, Oregon, Pennsylvania, Rhode Island, Texas, Utah and Virginia named
- Medical device recall VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605) Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNo state named
Nothing matches all of these.
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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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