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 Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control The label on the Tyvek bag is missing. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and West Virginia named
- Medical device recall RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of… Potential disassociation of the orientation pin. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500… The units have been fitted with a potentially faulty power supply cable. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall X-Ray Diagnostic Table Report of unintentional movement of table to reverse tilting. Class IIFDA’s classMay 4, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 4, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Fetch 2 Aspiration Catheter Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 27, 2016ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and US Virgin Islands named
- Medical device recall iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and… A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report21 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Maine, Missouri, Nebraska, Nevada, Oklahoma, Pennsylvania, Tennessee, Utah, Virginia and West Virginia
- Medical device recall Leica Microsystems (Schweiz) Ag An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is… Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Puerto Rico, Washington and Wisconsin
- Medical device recall CareLink iPro2 Reports Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR) Reports of an abnormally high frequency of squelch events on Xhibit Telemetry Receivers (XTR), which is indicative of the loss of the telemetry data signal. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Idaho, Indiana, Kentucky, Michigan, Minnesota, Missouri, Mississippi, Montana, South Carolina, Texas and Wyoming
- Medical device recall Ad-Tech Electrode Connection System/Cables Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereGeorgia and Michigan
- Medical device recall Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereColorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Missouri, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee and Texas
- Medical device recall Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereColorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Missouri, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee and Texas
- Medical device recall IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereColorado, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Missouri, North Carolina, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee and Texas
- Medical device recall VariAx Compression Plating System Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Robotic Arm Interactive Orthopedic System (RIO) Revision of the field manual Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading… OraSure Technologies, Inc. Class IIIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedApr 27, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Ossur Lil Angel Vest P2 Kodel There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ossur Lil Angel Vest P2 Lambswool There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ossur Lil Angel Vest P2 Sorbatex There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ossur Lil Angel Vest P3 Kodel There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ossur Lil Angel Vest P3 Lambswool There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ossur Lil Angel Vest P3 Sorbatex There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Michigan, Ohio, Texas and Washington named
- Medical device recall GDC-18 360 11MM X 30CM Detachable Coil Sterile The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Illinois, Michigan, Ohio, Texas and Washington named
- Medical device recall Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 27, 2016ClassClass 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 Hampshire, 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 SOMATOM Definition AS Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 27, 2016ClassClass 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 Hampshire, 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 SOMATOM Definition Flash Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 27, 2016ClassClass 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 Hampshire, 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 SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedApr 27, 2016ClassClass 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 Hampshire, 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 CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as… Class IIIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 27, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Missouri, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee and Texas named
- Medical device recall Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the… Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, North Carolina, New Jersey, New York and Texas named
- Medical device recall Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306 Coloplast Corp. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Florida, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall MEVION S250 for Proton Radiation Therapy Possibility of Gantry Motion with Aperture or Compensator only partially inserted. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New Jersey and Oklahoma named
- Medical device recall Acorn 180 Curved Stairlift Aluminum rivets holding the base squab to the framer under prolonged customer use were seen to elongate and subsequently break. Class IIFDA’s classApr 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, US Virgin Islands, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, 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… 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 Left, SIZE 8 LEFT, 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 Left, SIZE 10 LEFT, 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 2 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 6 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 8 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 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 Left, SIZE 4 LEFT, 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 Left, SIZE 6 LEFT, 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 Left, SIZE 8 LEFT, 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 4 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 6 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 8 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
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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