Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Dimension Thermal Chamber Motor Cable located in the following models Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. Class IIFDA’s classNov 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL. Class IIIFDA’s classNov 14, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 14, 2018ClassClass IIIStatusTerminatedWhereColorado and Iowa
- Medical device recall Cardiosave Hybrid IABP There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IStatusOngoingWhereNationwide
- Medical device recall Cardiosave Rescue IABP There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IStatusOngoingWhereNationwide
- Medical device recall BOND Slide Labeler Zebra Printer The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow AGB + Multi-Lumen CVC Kit The product was shipped after its expiry date due to a system error. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, North Carolina and Rhode Island named
- Medical device recall Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a… Expiration date on the label is incorrect. Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereNationwide, and California, Georgia, Minnesota, Oregon, Rhode Island, Texas and Wyoming named
- Medical device recall Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of… The product is labeled with an incorrect expiration date. Class IIIFDA’s classNov 7, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 7, 2018ClassClass IIIStatusTerminatedWhereFlorida and Tennessee
- Medical device recall Magellan LeadCare¿ II Blood Lead Test Kit Defect with the calibration button for lot 1808M. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated… Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 7, 2018ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall SpF PLUS-Mini Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedNov 7, 2018ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Maryland, Michigan, New York, Oklahoma and Pennsylvania named
- Medical device recall Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Maryland, Michigan, New York, Oklahoma and Pennsylvania named
- Medical device recall Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Maryland, Michigan, New York, Oklahoma and Pennsylvania named
- Medical device recall Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Maryland, Michigan, New York, Oklahoma and Pennsylvania named
- Medical device recall IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart Foreign material in product Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, New York, Oklahoma, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 Foreign material in product Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Michigan, New York, Oklahoma, Oregon, Pennsylvania, Texas and Washington named
- Medical device recall RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment… Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to… The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedNov 7, 2018ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Idaho, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Wisconsin named
- Medical device recall FilmArray Blood Culture Identification (BCID), IVD Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube… Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the… In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin and Wyoming
- Medical device recall Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic… In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin and Wyoming
- Medical device recall Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems… In rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement Report38 statesnamed in where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin and Wyoming
- Medical device recall Roche Diagnostics URISYS 1100 Urine Analyzer Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vereos PET/CT, Software version 2.0.1 Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray… It was reported that scanners running certain software versions provide confusing information in the “Impressions” section of the Calcium Score report. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Max Instrument Reader Spare Part A trend for false positive Candida glabrata results has been confirmed. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall BD Max Instrument A trend for false positive Candida glabrata results has been confirmed. Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Zilver 518 Biliary Stent 4mm x 20mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 4mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 4mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 4mm x 60mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 4mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 5mm x 20mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 5mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 5mm x 40mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 5mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 518 Biliary Stent 5mm x 80mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zilver 635 Biliary Stent 12mm x 30mm The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected… Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming 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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