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 Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PREC PRM 16FR SILVER FLY TY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PRECSION PRM 18FR SIL FLY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Dover PREC PRM 18FR SILVER FLY TY Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall QFT TB Antigen Tube Potential for obtaining a false positive result due to the possibility of endotoxin presence. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization,… After importing, the segmentation results appear mirrored at the CARTO system and can’t be used for the ablation procedure. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Minnesota, Montana and New York named
- Medical device recall cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and… Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereArizona, Georgia, Michigan, Ohio, Puerto Rico, Tennessee, Texas and Washington
- Medical device recall BioTex Reusable Adapter Kit Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereArizona, Florida, North Carolina and New Jersey
- Medical device recall KAMRA Inlay, ACI 7000 Corneal Inlay AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving… Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UltraxxTM Nephrostomy Balloon Set The Ultraxx” Nephrostomy Balloon Set consists of a radiopaque balloon… Cook Medical is voluntarily recalling specific lots of the Ultraxx” Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereGeorgia, Idaho, Louisiana, Oregon, South Carolina and Texas
- Medical device recall Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set… Cook Medical is voluntarily recalling specific lots of the Ultraxx” Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereGeorgia, Idaho, Louisiana, Oregon, South Carolina and Texas
- Medical device recall Alaris PC Unit, Infusion Pump CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Idaho, Illinois and Indiana named
- Medical device recall Dimension Vista LOCI Estradiol Test Code E2 The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Idaho, Illinois and Indiana named
- Medical device recall IMMULITE 1000 Estradiol Test Code E2 The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Idaho, Illinois and Indiana named
- Medical device recall IMMULITE 2000 EstradiolTest Code E2 The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results. Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Idaho, Illinois and Indiana named
- Medical device recall MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of… Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from “Completed (or… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereFlorida, New York, Ohio and Texas
- Medical device recall RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning… There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight… Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Irrigation Clip 30 Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498). Class IIFDA’s classMar 30, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereMinnesota and Pennsylvania
- Medical device recall Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Straight needle labeled as a curved needle Class IIFDA’s classMar 30, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMar 30, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Ohio and Oregon named
- Medical device recall Battery Pack KLS-SD-1000 Case The sterile battery may contain particulates within the sterile package. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered… The sterile battery may contain particulates within the sterile package. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall NuOSS Cancellous Intended for use in dental surgery. On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002… During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S Emergency helium venting lines (i.e. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin
- Medical device recall Product 1 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 2 consists of all products As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 3 consists of all products under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 4 consists of all products under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 5 consists of all products under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 6 consists of all products under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 7 consists of all products under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 8 consists of all products under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 9 consists of all product under HRS, and same usage As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 10consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 11 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 12 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 13 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 14 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 15 consists of all As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 16 consists of all product under poduct code: KWY and same usage As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 17 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 18 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 19 consists of all As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 20 consists of all prod oct under poduct code: KTT and same usage As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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