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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dexcom G4 PLATINUM Receiver Receiver Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Dexcom G4 PLATINUM (Professional) Receiver Receiver Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Dexcom G4 PLATINUM Receiver with Share Receiver Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Dexcom G5 Mobile Receiver Receiver Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by… Siemens became aware that the front cover on some Siemens CT system was not properly welded. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportOhiothe one state its words name PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by… The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by… The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body… The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by… The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body… The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by… The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia
- Medical device recall BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female… Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients… Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder… Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arthrex Deltoid Ligament Reconstruction Implant System Potential for a component contained in the Implant System to be non-sterile. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report22 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas and Wisconsin
- Medical device recall Neurotherm NT2000iX RF Generator NT2000iX software shipped with the international setting turned on. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Iowa, Maine, New Jersey, New York, South Carolina, Texas and Wisconsin
- Medical device recall USE (Ebony) PTA .014” rapid exchange (RX) Peripheral Dilatation Catheter Product may kink during use rendering the product unusable. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Louisiana, Michigan, Missouri, Mississippi, New York, Tennessee and Texas
- Medical device recall Medix NatalCare ST-LX Intensive Care Incubator NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that the screws holding the port in place can become loose… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Diana Automated Compounding System, Diana Onco Plus ICU Medical Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Diana Automated Compounding System, Diana Onco Plus 1.2 ICU Medical Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Diana Automated Compounding System, Diana Onco Plus 1.3 ICU Medical Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Diana Automated Compounding System, Diana Onco 3xx ICU Medical Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Diana Automated Compounding System, Final Assembly, Diana Onco Plus ICU Medical Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Diana Automated Compounding System, Diana V1.3 ICU Medical Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN… Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Maine and Tennessee named
- Medical device recall QUADROX-i oxygenators Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Tubing Packs Custom tubing pack for oxygenators Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific TSX Transseptal Needle Merit Medical Systems, Inc. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall da Vinci S Surgical System (IS4000) user manual English and OUS Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The… The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Illinois, Indiana, Maryland, Michigan, Minnesota, New York, Pennsylvania, South Carolina, Tennessee, Virginia, Washington and Wisconsin
- Medical device recall SurgiCounter scanner, part of the SurgiCount Safety-Sponge System The affected scanner does not correctly interact with the SC360 software. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Louisiana, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, New York, Ohio, South Carolina, South Dakota, Tennessee, Texas and Utah named
- Medical device recall EPIQ DIAGNOSTIC ULTRASOUND SYSTEM The fasteners securing the control panel assembly to the base of the Philips EPIQ Ultrasound System may loosen over time, which could subsequently lead to the… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall GE Healthcare, Aisys CS2 anesthesia.. GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report41 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall GE Healthcare, Aisys Carestation. GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report41 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing… It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing… It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing… It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing… It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing… It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in… Class IIFDA’s classApr 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of… Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose. Class IIFDA’s classApr 20, 2016in FDA’s Enforcement Report36 statesnamed in where it went PublishedApr 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Cygnus Medical First StepBedside ADDWATER Kit,non-sterile Foreign material in container Class IIIFDA’s classApr 20, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedApr 20, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Minnesota, Montana, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont, Washington 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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