Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall GE Healthcare, Dash 3000/4000/5000 GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Patient Circuit used with the Life Pulse High Frequency Ventilator Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or… GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement Report41 statesnamed in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wyoming
- Medical device recall EEG NeuroAmp EEG Info, Inc. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp) It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Michigan, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are… Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Illinois and New Jersey named
- Medical device recall Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export… Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medline Total Knee CDS The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and West Virginia named
- Medical device recall Biomet Offset Tibial Tray 2.5 mm Adaptor Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Iowa, Idaho, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm… Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Nevada named
- Medical device recall Biomet Polaris 5.5 Button Lock Screw Inserter Broken screw insertor hardness was measured and found to be below the acceptable limits. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Missouri and Texas named
- Medical device recall COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW… Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium… Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used… All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach,… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Invacare Height Adjustable (walking) Canes Following their receipt of several customer complaints, Invacare recalled their height adjustable walking canes. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ThyssenKrupp Accessibility LEVANT Stairlift The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall MAYFIELD Composite Series Base Unit An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MAYFIELD Composite Series Skull Clamps An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5… GE Healthcare has became aware of two issues with the Advantage Workstation. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement Report31 statesnamed in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall AutoTac Delivery Handle The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Titanium Tack Starter Kit The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and North Carolina and Oklahoma named
- Medical device recall The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer… Model 6390 Power-LOAD systems built between September 12, 2012 and September 27, 2012 may have been built with a load switch slide that does not meet… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Iowa, Illinois, Michigan, Missouri, New Mexico, New York, Pennsylvania, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Medtronic, DBS Extension Kit for Deep Brain Stimulation Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Michigan, New Hampshire, New York, Ohio, Pennsylvania and Vermont named
- Medical device recall Medline Angio Drape Pack Radiology-LF The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and New York named
- Medical device recall Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector DePuy Orthopaedics, Inc. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Massachusetts, Minnesota, South Carolina and Virginia named
- Medical device recall BD Phoenix PMIC-108 Panels An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria. Class IIFDA’s classDec 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Kentucky, Oklahoma, Rhode Island, Wisconsin and Wyoming named
- Medical device recall SpineSix consists of a motorized treatment table that is controlled by an integral computer BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory… Class IIFDA’s classDec 26, 2012in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 26, 2012ClassClass IIStatusTerminatedWhereFlorida, Georgia, New Jersey, New York, Pennsylvania, Tennessee 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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