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 6, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters Product gives incorrect low blood glucose levels. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedOct 5, 2016ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, 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 and West Virginia named
- Medical device recall DRI Salicylate Serum Tox Assay Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Missouri, Puerto Rico and Texas named
- Medical device recall Spacelabs Healthcare Xhibit Central Station The firm received multiple reports of Xhibit Telemetry System going offline or locking up. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Spacelabs Healthcare Xhibit Telemetry Receiver (XTR) The firm received multiple reports of Xhibit Telemetry System going offline or locking up. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determination of soluble transferrin… R&D Systems, Inc. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Kentucky, Louisiana, Massachusetts, Maryland, New Jersey, Ohio, Rhode Island, Utah, Virginia and Washington
- Medical device recall Spiegelberg Brain Pressure Monitoring System Probe 3PN In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall ETHICON MERSILENE” Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) ETHICON MERSILENE” Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of… Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The EKOS cart has the Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Syngo.plaza, Picture Archiving and Communication System Software upgrade to eliminate several issues Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.plaza VB10A, Picture Archiving and Communication System Software upgrade to eliminate several issues Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zyno Medical Administration Set, Sterile Administration Set potential filter leaking Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zyno Medical Administration Set, Sterile Administration Set potential filter leaking Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zyno Medical Administration Set, Sterile Administration Set potential filter leaking Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zyno Medical Administration Set Sterile Administration Set potential filter leaking Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BruxZir Shaded Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was… Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Indiana, Minnesota, North Carolina, Oregon, South Carolina, Washington and Wyoming named
- Medical device recall CareLink iPro Version 1.10 Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide, and Minnesota, Tennessee and Washington named
- Medical device recall Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using… Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUIOS CL Flow Cytometer Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Illinois, New York, Pennsylvania, South Carolina and Washington
- Medical device recall FPS 35mm x 3.5 mm non-locking screw Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sealapex Xpress SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall G1 Dissection Tool - 7mm FBALL L Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Maryland, Michigan and Oregon
- Medical device recall G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Maryland, Michigan and Oregon
- Medical device recall G1 Dissection Tool - 3mm FLUTED BALL The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Maryland, Michigan and Oregon
- Medical device recall G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereArizona, California, District of Columbia, Maryland, Michigan and Oregon
- Medical device recall IG1, IGF-I reagent 24 minutes of incubation is required prior to processing patient samples and for the pretreatment solution to reach full equilibration when using pretreatment… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereFlorida, Illinois, Louisiana, Massachusetts, Missouri, New York and Ohio
- Medical device recall HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A The handle can separate from the MRx housing due to breakage of mounts on the rear case. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in… OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Kentucky, Michigan, Minnesota, Missouri, New York, Ohio, Oregon, Rhode Island, Tennessee, Texas, Virginia and Washington named
- Medical device recall 3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in… OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Kentucky, Michigan, Minnesota, Missouri, New York, Ohio, Oregon, Rhode Island, Tennessee, Texas, Virginia and Washington named
- Medical device recall 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile Product was incorrectly packaged. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medical device recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereIllinois
- Medical device recall RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile… Sterility seal integrity failures on the Renasys Sterile Transparent Film Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 28, 2016ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall TriMed Semi-Tubular Plate, 10-Hole TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Hawaii, Indiana, Missouri and Wisconsin named
- Medical device recall Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium Products contain international package insert and not the correct USA package insert Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and California, Georgia and New York named
- Medical device recall Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number:… Products contain international package insert and not the correct USA package insert Class IIIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 28, 2016ClassClass IIIStatusTerminatedWhereNationwide, and California, Georgia and New York named
- Medical device recall Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for… Software error. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for… Software error. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter The recalling firm identified ten devices which were distributed and could potentially be non-compliant. Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SENSAR Foldable IOL with OptiEdge Design Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS Multifocal 1-Piece Intraocular Lens Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS Symfony Extended Range of Vision IOL Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS 1-Piece IOL Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS OptiBlue 1-Piece Intraocular Lens (IOL) Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SENSAR 1-Piece IOL Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall TECNIS Multifocal Foldable Acrylic Intraocular Lens Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of… Class IIFDA’s classSep 28, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 28, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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.”
Your shortlist0 of 4
Add one more to compare.