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 INFINITI Ultrasound Pack The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems The docking station top cover of the removable patient table may contain a magnetic metal plate. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Minnesota, New York, Ohio, Tennessee and Virginia named
- Medical device recall Smart CR Digital Computed Radiography System Reports of failure of the device’s power supply. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Syngo Dynamics Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Poly-bags containing splint strap labeled with “Pediatric” sticker On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall Poly-bags containing the strap labeled with “Adult” sticker On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall Medtronic CareLink” Monitor A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Alaris PC unit The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic… Class IIFDA’s classMay 11, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Toshiba American Medical Systems Celesteion Potential degradation of detector performance. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereNevada and Wisconsin
- Medical device recall TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO The firm received a complaint of an open pouch which breaches the sterilization validation. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report28 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY The firm received a complaint of an open pouch which breaches the sterilization validation. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report28 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY The firm received a complaint of an open pouch which breaches the sterilization validation. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report28 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure. The firm received a complaint of an open pouch which breaches the sterilization validation. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report28 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular… MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Class IIFDA’s classMay 11, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 11, 2016ClassClass IIStatusTerminatedWhereCalifornia, North Carolina and Ohio
- Medical device recall Trinity Acetabular System Product Usage - Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Massachusetts, North Carolina, Ohio, Oklahoma and Texas named
- Medical device recall Trinity Acetabular Shell Product Usage: Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Massachusetts, North Carolina, Ohio, Oklahoma and Texas named
- Medical device recall Trinity Acetabular Shell Product Usage Total Hip Replacement. Potential for abrasion of the sterile barrier pouches of the new packaging system. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Idaho, Massachusetts, North Carolina, Ohio, Oklahoma and Texas named
- Medical device recall ev3, PowerCross” 0.018” OTW PTA Dilatation Catheter Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018” ¿ Over the Wire (OTW) Percutaneous Transluminal… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Louisiana, Michigan, Missouri, Mississippi, New Hampshire, Nevada, New York, Ohio, Pennsylvania, South Dakota and Texas
- Medical device recall ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top… Horiba Instruments, Inc. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry… Horiba Instruments, Inc. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia and Wyoming named
- Medical device recall Spirit One A-C Powered Hospital Bed Customer complaints associated with faulty brake system Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Spirit One A-C Powered Hospital Bed Inaccurate scale systems Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report19 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, Florida, Georgia, Hawaii, Iowa, Illinois, Kansas, Louisiana, Michigan, Minnesota, Missouri, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood… The adherence check generates a software error. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereFlorida, Kansas, Massachusetts, Michigan, Mississippi and Pennsylvania
- Medical device recall SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of… The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Iowa, Illinois, Kentucky, Massachusetts, Maryland, Minnesota, Montana, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Carolina, Texas and Washington named
- Medical device recall Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall Aquilion Lightning CT System iStation cover, SID: 70000246 Toshiba American Medical Systems, Inc. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNevadathe one state its words name PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNevada
- Medical device recall Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic… The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare, Aisys and Aisys CS2 The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 3M discovered a valve with incorrectly labeled “input” and “output” orientation. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Colorado, Connecticut, Florida, Georgia, Indiana, North Carolina, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, Virginia and Wisconsin
- Medical device recall Magellan Robotic Catheter Accessory Kits Firm’s quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Ohio and Texas named
- Medical device recall Automated peritoneal dialysis (APD) cycler Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNew York
- Medical device recall PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number:… Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Massachusetts and Texas named
- Medical device recall EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Hawaii, Iowa, Illinois, Kansas, Maryland, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas and Wisconsin named
- Medical device recall enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Maryland, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee and West Virginia
- Medical device recall BD Trucount Absolute Counting Tubes One lot of lot of BD Trucount tubes may contain tubes from another lot. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Delaware, Florida, Georgia, Louisiana, Maryland, Minnesota, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Virginia and Washington
- Medical device recall Hardy Diagnostics GBS Detect Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Illinois, Indiana, Massachusetts, Michigan, North Carolina, Ohio, South Carolina, Texas, Virginia, Wisconsin and West Virginia
- Medical device recall ACUSON X700 Ultrasound System with software version 1.0.04 Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system… The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereConnecticut, Florida, Louisiana, Missouri, North Carolina, Nebraska, Ohio, Puerto Rico, South Carolina and Texas
- Medical device recall 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereIllinois and Indiana
- Medical device recall Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time,… Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST)… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Drew Scientific Inc The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New York, South Carolina, Tennessee and Texas
- Medical device recall Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CF InPlex ASR Card Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, Washington and West Virginia
- Medical device recall Hologic InPlex CF Molecular Test (IVD) Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such… Class IIFDA’s classMay 4, 2016in FDA’s Enforcement Report30 statesnamed in where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas, Washington and West Virginia
- Medical device recall reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain… Incorrect Power Supply in the package, rendering the device inoperable. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 4, 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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