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 VITROS 250 Chemistry Systems Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 350 Chemistry System Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 4600 Chemistry System Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5600 Chemistry System Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS 5,1 FS Chemistry System Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare… The sterility of the product cannot be assured. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereCalifornia and Utah
- Medical device recall Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension Potential for the parts to crack. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereMinnesota, New York and Pennsylvania
- Medical device recall Stryker Position Pro Mattress Potential for power cord to melt; hazards include electric shock and fire. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Crosslock DVR ePAK -Sterile Components of the DVR ePAKs can oxidize during shipment and storage prior to use. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TF Adaptive Gutta Percha Point Size SM3 50pk Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mobile wDR motorized portable diagnostic X-ray systems This is related to previous 806 Notifications about uncommanded movements of a motorized mobile x-ray system. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Medtronic 0-arm 02 Imaging System Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and… Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in… Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereMichigan, New Jersey, Pennsylvania and Texas
- Medical device recall ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only Customer complaints about failed target ranges for alpha angle. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report27 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington and West Virginia
- Medical device recall BladderScan BVI 9600 The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Healthcare Xhibit Central Station The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a… Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report34 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming
- Medical device recall Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive… Zimmer Biomet Inc. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report31 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and West Virginia
- Medical device recall Virage OCT Spinal Fixation System Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BrightView are gamma cameras The firm discovered four issues with the BrightView Family systems. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BrightView X are gamma cameras The firm discovered four issues with the BrightView Family systems. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall BrightView XCT & BrightView XCT Upgrade, gamma cameras The firm discovered four issues with the BrightView Family systems. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes… Class IIIFDA’s classMar 9, 2016in FDA’s Enforcement Report25 statesnamed in where it went PublishedMar 9, 2016ClassClass IIIStatusTerminatedWhereAlaska, Arizona, California, Delaware, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Ohio, Oregon, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall SENSE Body Coil 1.5T with identification Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Karma Flexx Wheelchair Manual Wheelchair. Karman Healthcare, Inc. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereCalifornia, New York, Texas and Washington
- Medical device recall Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art Complaints were received claiming the material failed to polymerize under the curing light. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Indiana, New York, Pennsylvania and Texas named
- Medical device recall NeoCoil 3.0T GEM Flex Coil Potential for higher than specified surface temperatures. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip… Product potentially exposed to body fluids during processing. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Illinois, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New York, Ohio, Oklahoma and Pennsylvania named
- Medical device recall ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental… Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall PINPOINT Endoscopic Fluorescence Imaging System It has been determined that the PINPOINT Operator’s Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall PICC/CVC Secure Dressing Change kit Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Missouri, Nebraska and Texas named
- Medical device recall (Stryker) AccuPlace Straight Level Needle Guide During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall (Stryker) AccuPlace Round Level Needle Guide During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Volcano R100 Sterile Equipment Cover Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volcano SpinVision Sterile Equip cover II Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping… Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo… Aesculap Inc. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form… The Nebulizer mask malfunctions in that there is reduced or no aerosol output. Class IIFDA’s classMar 9, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maine, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Maquet Getinge Group 1180.19XO Extension Device MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). Class IIFDA’s classMar 9, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 9, 2016ClassClass IIStatusTerminatedWhereArizona and Missouri
- Medical device recall WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal… “The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Puerto Rico and US Virgin Islands named
- Medical device recall GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic… It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Indiana, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Vermont, Washington and Wisconsin
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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