Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall FirmArray Blood Culture Identification (BCID) Panel BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioM¿rieux… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall Puritan Bennett 840 Ventilator Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, 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 Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia and Wyoming named
- Medical device recall ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for… Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding. Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) Separation events have occurred, including the VIPR separating from the Aluminum cylinder. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, 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, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting… Potential for the welded seam in affected monitor spring arms to crack and/or break. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereMassachusetts, New York, Ohio, Pennsylvania and Texas
- Medical device recall RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement “Caution: This product contains… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Healthcare Qube Compact Monitor Spacelabs Healthcare is recalling Qube Compact Monitor, Model 91390, due to a potential chance of losing network connection after switching from hardwired… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report35 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall RT-5100 Refractor and RT-3100 Refractor Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ingenia 3.0T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Maine, Michigan, New York, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Ingenia 1.5T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Maine, Michigan, New York, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Ingenia 3.0T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Maine, Michigan, New York, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Ingenia 1.5T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Georgia, Maine, Michigan, New York, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection… While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Siemens StreamLAB(R) Analytical Workcell Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module, which protrude approximately… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Accell Evo3C Demineralized Bone Matrix, 5 cc This lot of Accell Evo3C Demineralized Bone Matrix, 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Virginia, Vermont and Washington named
- Medical device recall IS4000 da Vinci Xi - Endoscope accessory In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereFlorida, New York and Texas
- Medical device recall IS4000 da Vinci Xi - Endoscope accessory In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereFlorida, New York and Texas
- Medical device recall Shaver Handpiece Sterilization Tray STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. JAS Diagnostics, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia and West Virginia
- Medical device recall IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode.… Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to… Class IIFDA’s classJul 2, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
- Medical device recall ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used… The Anspach Effort, Inc. Class IIFDA’s classJul 2, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 2, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Iowa, Illinois, Kentucky, Minnesota, Mississippi, North Carolina, Ohio, Oklahoma, Pennsylvania and Tennessee
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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