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 Merge Cardio software Patient information in the header is only found on the first page of the report and not on the subsequent pages. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage:… Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Hawaii, Kansas, Massachusetts, North Carolina, Texas and Utah named
- Medical device recall Philips Expression Information Portal (IP5) Frozen Display Numerics and Disabled Menu Keys after extended run time. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379 Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Sertera Biopsy Device, Sterile Incorrect label on the Sertera Biopsy Kit Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12”, Sterile The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall CADstream software An incorrect biopsy or missed target could result if the incorrect grid is selected within the application. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication… The STAT priority icon was not displayed in the Study List when the study was opened. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report40 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician… Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of… Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source),… Pentax America Inc. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fluorocell PLT reagent There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereFlorida, Maryland, North Carolina and Ohio
- Medical device recall Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning… Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereFlorida, Maryland, North Carolina and Ohio
- Medical device recall Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation. Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereFlorida, Maryland, North Carolina and Ohio
- Medical device recall Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide… Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereFlorida, Maryland, North Carolina and Ohio
- Medical device recall Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1 Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereFlorida and New York
- Medical device recall CARTO 3 EP Navigation System and Accessories Biosense Webster, Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Integra Meshed Dermal Regeneration Template 5 cmx 5 cm Integra’s post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall LDX Optical Check Cassettes (OCC) Incorrect expiration date on the magnetic strip that does not match the labeled expiration date. Class IIIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedSep 21, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New York, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the… Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. Class IIIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 21, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, South Carolina, Texas, Virginia and West Virginia named
- Medical device recall Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction… The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction… The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD The product lot failed to meet QC acceptance criteria during stability testing. Class IIIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 21, 2016ClassClass IIIStatusTerminatedWhereNationwide, and California named
- Medical device recall GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap Potential for glass particles within the vials Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker Orthopaedics Patella Assembly Instrument Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03,… Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereConnecticut, Hawaii, Iowa, Massachusetts, Maine, Michigan, Minnesota, North Dakota, New Jersey, New York, Pennsylvania, Texas and Wisconsin
- Medical device recall Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable… Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems… Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read,… Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate,… Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T2Candida¿Cartridges Elevated levels of invalid results. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Indiana, Louisiana, Michigan, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and Wisconsin
- Medical device recall RadSuite software Multiple studies were missing at a customer location that never made it to the archive before watermarking Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Oklahoma named
- Medical device recall Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585,… There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817,… There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857,… There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392 There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393 There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394 There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395 There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those… Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The VITROS¿ Chemistry Products Calibrator Kit 31 There is an incorrect value (data/calibration mathematics) on ADDs. Class IIIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedSep 21, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and West Virginia named
- Medical device recall Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60” TUBING, Disposable Transducer, 3 ML… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 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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