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 IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the… Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Utah, Washington, Wisconsin and Wyoming named
- Medical device recall Bard Distaflo Vascular Bypass Graft Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereAlabama, California and Texas
- Medical device recall Bard Distaflo Vascular Bypass Graft Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereAlabama, California and Texas
- Medical device recall SIGMA HP MBT Non-Keel Punch Knee Instrument Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical… Cytotoxicity tests were not passed at 36 months. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report47 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, 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, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Reuseable rotary blade/abrader, product number 899751305 Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Reuseable rotary blade/abrader, product number 899751504 Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Reuseable rotary blade/abrader, product number 899751514 Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereWashington
- Medical device recall Mizuho OSI Trios, Table Base Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Smith & Nephew BEAVER Blade 4.0mm Blade exhibiting fracture during hip arthroscopy procedures Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RadSuite, a picture archive and communications system Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic,… Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+) Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Texas and Virginia named
- Medical device recall T-piece Nebulizer with in-line connectors Reports that the T-piece does not fit on the nebulizer. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNew York, Ohio, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical… There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. Class IIFDA’s classFeb 17, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 17, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Drager became aware of situations where the error message “Poti unplugged” was generated causing acoustic and visual alarms, the breathing system releases… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 10, 2016ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Drager became aware of situations where the error message “Poti unplugged” was generated causing acoustic and visual alarms, the breathing system releases… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedFeb 10, 2016ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc. Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws Driver does not meet specification, oversized. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Colorado, Florida, Illinois, Indiana, Michigan, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws Driver does not meet specification, oversized. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, California, Colorado, Florida, Illinois, Indiana, Michigan, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Panorama Patient Monitoring Network An issue with the Panorama Central Station may cause the system to spontaneously restart. Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Allura Xper FD10, FD10 C, and FD10 F The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD10/10 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD10 OR Table The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20/10 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20/15 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: “ Vascular,… The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall UNIQ FD OR table The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20 OR Table The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20 Biplane The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20 Biplane OR Table The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20/20 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura Xper FD20/20 OR Table The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and… The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cardiovascular Allura Centron The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS H3000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS HM3000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS BN/BV3000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS BH3000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall INTEGRIS V3000 The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being… Class IIFDA’s classFeb 10, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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