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 Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro… Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report36 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES Reported failure of the instrument. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereColorado, Idaho and Texas
- Medical device recall Parker Trach-Vac Endotracheal Tubes Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction,… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kentucky, Missouri, Tennessee and Texas named
- Medical device recall Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable… Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNew York
- Medical device recall Syngo.via, picture archiving and communications system software controlled Incorrect values for the volume calculation. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Utah named
- Medical device recall DeVilbiss Model 7305P-D Powered Suction Unit A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereFlorida, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Texas and Wisconsin
- Medical device recall The Synchron Systems No Foam DxC (Reference No Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and the DxC hydropneumatic parts associated with No Foam delivery. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJul 27, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall OT1000 Series Orthopedic Surgical Tables STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report25 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah and Virginia
- Medical device recall Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Product did not meet specifications for Zinc Acetate (OOS). Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY… Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereIowa, Indiana, Kansas, Kentucky, Montana and South Dakota
- Medical device recall BD Trucount Tubes One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report17 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Indiana, Kentucky, Massachusetts, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Virginia, Washington and Wisconsin
- Medical device recall Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones… The graphics at the attachment interface indicating locked and unlocked position are reversed. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereFlorida and Georgia
- Medical device recall cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device… During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated “No Mutation Detected”… Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN… Eight (8) issues were identified which may affect the results generated by the system software version. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Maryland, Minnesota and Mississippi named
- Medical device recall HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V Heartware Ventricular Assist System Battery Cell experiencing premature depletion. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 20, 2016ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients… Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 20, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general… Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 20, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall LifeCare PCA infusion system with Hospira MedNet software allows clinicians to administer, or patients to… Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 20, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall The LifeCare Pump Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 20, 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall enGen Laboratory Automation System If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM… Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Merge OfficePACS software Potential data loss occurs as a result of the software archiving not working properly. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No.… Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction… Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80 Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereArizona, California, Louisiana, Michigan, North Carolina, Nebraska, New Mexico, New York, Oklahoma, Pennsylvania, Texas, Virginia and West Virginia
- Medical device recall AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and… Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Missouri, Ohio, Tennessee and Texas named
- Medical device recall Breathe Right Clear, 30 ct Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian’s TrueBeam EDGE Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optical Surface Monitoring System{Align RT Plus} This is used on Varian’s TrueBeam EDGE Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 6.5 mm Cannulated Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 6.5 mm Cancellous Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 7.0 mm and 7.3 mm Cannulated Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 4.0 mm Cortex Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 4.5 mm Cortex Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 4.5 mm Cannulated Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 3.5 mm and 4.0 mm Cannulated Screw Labeling does not match the cleared indications for use in the United States and Canada. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 20, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Merge OfficePACS software Potential data loss occurs as a result of product archiving not working properly. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report23 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Massachusetts, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Virginia and Washington
- Medical device recall Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
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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