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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall INTEGRIS H5000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS BH5000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS V5000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS BV5000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS Allura 9 (biplane) The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS Allura 15-12 (mono) The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS Allura 15-12 (biplane) The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and… The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS BV3000 MONO The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Baxter, RAPIDFILL Syringe Strip, 10 ml All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PS-500 Scope Warmer Damage to package seals potentially compromising sterility. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MediChoice Cohesive Bandages, One MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MediChoice Cohesive Bandages, One MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MediChoice Cohesive Bandages, One MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HemosIL Plasminogen This Lot is not meeting labeled on-board instrument stability claims of 5 days. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall The ABX PENTRA Cholesterol CP ref N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall ABX PENTRA Enzymatic Creatinine CP ref N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall ABX PENTRA Glucose PAP CP ref N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall ABX PENTRA Lactic Acid CP ref N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall ABX PENTRA Triglycerides CP ref N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall ABX PENTRA Uric Acid CP ref N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report29 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold… Reports related to ingress of air into the manifold. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri and Ohio named
- Medical device recall Astral 100, 150 Resmed Corporation is recalling Astral 100, 150 External Battery because of a start-up issue. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report31 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming
- Medical device recall Synthes Small Electric Drive (SED) The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Hawaii, Idaho, Illinois, Kansas, Louisiana, Michigan, North Carolina, New York, Texas, Virginia and Washington named
- Medical device recall AQURE System The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Florida, Georgia, Massachusetts, Michigan, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall BacT/ALERT¿ SN, bioM¿rieux, Inc Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿… Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and impact growth performance. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVIA Centaur PSA Assay PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU). Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests… Multiple Software issues. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Massachusetts, New York, Texas and Washington named
- Medical device recall API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of… Discrepant identification results related to API identification strips. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to… Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage… Failure of the primary collimator may result in unintentional movement of the device. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report34 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate… Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue The cannulae may bend during procedure. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, New Jersey and New York
- Medical device recall Fresenius Liberty Cycler-Peritoneal Dialysis Cycler The door latch may not fully close and the door may open unexpectedly. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fuse 1C Colonoscope The bending section of the device may partially separate from the insertion tube. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall D-10 Rack Loader On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro… All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Class IIFDA’s classFeb 3, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 3, 2016ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Illinois, Michigan, Montana, North Carolina, New Jersey, New Mexico, New York, Oregon, Pennsylvania and Texas named
- Medical device recall Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic Software Error: The effect of setup on overall navigation accuracy could potentially intensify small inaccuracies arising from individual steps of a complex… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall arkray SPOTCHEM II Glucose Reagent test strips One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 27, 2016ClassClass IStatusTerminatedWhereFlorida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee
- Medical device recall arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 27, 2016ClassClass IStatusTerminatedWhereFlorida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee
- Medical device recall Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the ‘Verify Heartbeat Detection’ feature and exhibit the potential for decreased… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereIllinois, Kansas, North Carolina and Texas
- Medical device recall FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades Product is incorrectly labeled. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereMaine, Michigan, Ohio and Texas
- Medical device recall FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades Product is incorrectly labeled. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereMaine, Michigan, Ohio and Texas
- Medical device recall FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades Product is incorrectly labeled. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereMaine, Michigan, Ohio and Texas
- Medical device recall VNS Therapy AspireSR Generator Recall being initiated in response to three reports of “Burst Watchdog Timeout” events occurring with the Model 106 AspireSR Generator, resulting in a device… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNo state 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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