Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only) Lack of an adequate sterilization validation. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive… The products do not have sufficient data to support the labeled shelf life of 10 years. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the… The products do not have sufficient data to support the labeled shelf life of 10 years. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D Potential for a transducer mis-alignment in certain transvaginal probes. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D Potential for a transducer mis-alignment in certain transvaginal probes. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall BD Microtainer Tube w/ BD Microgard Closure, K2EDTA additive The products have been confirmed to have reduced or no additive within the tube reservoir. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas and Virginia
- Medical device recall Alpha Conducting solution Potential for failed stability antimicrobial effectiveness testing. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont and West Virginia named
- Medical device recall ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution. Potential for failed stability antimicrobial effectiveness testing. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont and West Virginia named
- Medical device recall ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution. Potential for failed stability antimicrobial effectiveness testing. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont and West Virginia named
- Medical device recall ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution. Potential for failed stability antimicrobial effectiveness testing. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont and West Virginia named
- Medical device recall Alpha Conducting solution Potential for failed stability antimicrobial effectiveness testing. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont and West Virginia named
- Medical device recall A-CIFT SoloFuse Fixed Angle Driver There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereArizona, Florida, Maryland and Missouri
- Medical device recall RUSCH CARE Premium Drain bag, 2000mlm The device labels are not UDI compliant. Class IIIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall RUSCH Urinary Drainage bag, 2000mlm The device labels are not UDI compliant. Class IIIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall TAPSYSTEM Model 2A, REF 8002A There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly. Class IIIFDA’s classJul 24, 2019in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 24, 2019ClassClass IIIStatusTerminatedWhereArkansas, New Mexico, Pennsylvania, Texas and Washington
- Medical device recall Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading… Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Indiana, Louisiana, Massachusetts, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading… Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report14 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Indiana, Louisiana, Massachusetts, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington
- Medical device recall The Tina-quant lgA Gen.2 is an immunoturbidimetric assay Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1… Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereAlabama, Indiana and Kentucky
- Medical device recall Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is… The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereTexas and Wisconsin
- Medical device recall DeRoyal THE RESOURCE GROUP, CRANI PACK Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge… Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereOklahoma
- Medical device recall Kaluza C Flow Cytometry Software Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medical device recall Olympus WM-NP2 or WM-DP2 Mobile Workstations with Nurse Control Panel Arm WM-NP/DP2 workstations could become unstable and may fall over if the control panel arm is mounted with a video monitor weighing more than 19.8 pounds. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 24, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Anti-fog solution The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 24, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in… The product may not meet sterility requirements. Class IIFDA’s classJul 24, 2019in FDA’s Enforcement ReportOklahomathe one state its words name PublishedJul 24, 2019ClassClass IIStatusOngoingWhereOklahoma
- Medical device recall Erisma- LP posterior fixation system with the below specifically affected products: 1 Potential for the polyaxial screw to become disassembled during implant. Class IIIFDA’s classJul 24, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 24, 2019ClassClass IIIStatusTerminatedWhereNationwide, and California, Illinois, Indiana, New York, Ohio and Texas named
- Medical device recall Alaris Pump Infusion Set An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 17, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates… The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 17, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates… The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 17, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed… New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedJul 17, 2019ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC,… The AC power module may fail at a higher than expected rate. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label… The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming
- Medical device recall ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label… The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report34 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusOngoingWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington and Wyoming
- Medical device recall Revive Reusable Bladder Support The product is unable to meet the use life of 31 cycles and may split or crack at the base of the “petals” after repeated use but within the use life of the… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Indiana, Kentucky, Montana, New York, Ohio, Pennsylvania, South Carolina and Wyoming named
- Medical device recall Cios Alpha VA20/ VA30 mobile X-Ray systems DAP chamber may be missing an insulating foil Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIllinois and Nebraska
- Medical device recall Cios care fusion system DAP chamber may be missing an insulating foil Class IIFDA’s classJul 17, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereIllinois and Nebraska
- Medical device recall MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005… The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03. Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Missouri, Rhode Island and South Carolina named
- Medical device recall Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The… software malfunction; It was found when a user performs radiography using the wireless flat panel detector (FPD), a message window displays on the monitor… Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Florida, Georgia, Illinois, Louisiana, Michigan, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Vermont, Wisconsin and West Virginia named
- Medical device recall Kii Fios First Entry, 5 X 75 mm The product may not have met sterility requirements . Class IIFDA’s classJul 17, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 17, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable 25GA Vitrectomy Cutter Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Class IIFDA’s classJul 10, 2019in FDA’s Enforcement Report10 statesnamed in where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, North Carolina, New Jersey, Nevada, New York, Ohio, Texas, Utah and Washington
- Medical device recall Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed… Class IIFDA’s classJul 10, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 10, 2019ClassClass 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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