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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Product 69 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 70 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 71 consists of all product under As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Product 72 consists of all As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover Class IIFDA’s classMar 23, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Iowa, Idaho, Illinois, Massachusetts, Minnesota, Montana and North Dakota
- Medical device recall Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek… Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as:… The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereTexas
- Medical device recall CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and… Incorrect cannula of the sheath introducer (smaller than intended). Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients… It was identified that in some situations the bed exit alarm may not function as intended. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volk G-4 Small Ring, No Flange, Gonio Lens with case The firm discovered that the incorrect lot number was engraved on the product. Class IIIFDA’s classMar 23, 2016in FDA’s Enforcement ReportVirginiathe one state its words name PublishedMar 23, 2016ClassClass IIIStatusTerminatedWhereVirginia
- Medical device recall Pilling Modular Verres Body/Obturator Packaging error in which customers who ordered product code 140880 (Verres cannula for use with a separately available needle tip) were incorrectly provided… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportUtahthe one state its words name PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereUtah
- Medical device recall Alaris Pump VersaSafe Infusion Set CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportMichiganthe one state its words name PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereMichigan
- Medical device recall Quick Connects The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two inlet ports as… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Puritan Bennett 980 Ventilator System, PB980 Ventilator Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR)… McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Siemens’ conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, Minnesota, Montana, North Carolina, Nebraska, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and West Virginia
- Medical device recall Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher The hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Florida, Minnesota, Montana, North Carolina, Nebraska, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah and West Virginia
- Medical device recall Stockert Heater-Cooler 3T On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Short Percutaneous Antenna with Thermosphere” Technology Standard Percutaneous Antenna with Thermosphere”… Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint” Percutaneous Antenna with Thermosphere” Technology due to the… Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record… Supplier of the “VESA 75 / 100 adaptation with rotation”, which is part of their monitor mounts and support arms may be missing riveting. Class IIFDA’s classMar 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMar 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, North Carolina, Pennsylvania, Texas and Virginia named
- Medical device recall MitraClip Clip Delivery System, product number MSK0101 Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GlideScope Titanium Single-Use Video Laryngoscope The firm has become aware of the potential for disruption (flickering) in the video laryngoscopy image when GlideScope Titanium SU laryngoscope blades are in… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall M/L Taper Hip Prosthesis (Item: 00-7711-012-20 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereKentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota and Tennessee
- Medical device recall Large Volume Paracentesis Kit is Customers have reported that the pinch clamp on the RP Bag was missing. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Iowa, Kentucky, Massachusetts, Missouri, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina and Tennessee
- Medical device recall LightSpeed Ultra GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated… GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated… GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System… GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LightSpeed Plus GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LightSpeed QX/I GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Milex Arcing Diaphragm Size 95 The products have been identified to contain an incorrect size Diaphragm. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNew York and Oregon
- Medical device recall FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy… The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ultra 8 IAB: 8Fr 30cc The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall FiberOptix Ultra 8 IAB: 8Fr 40cc The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Ultra 8 IAB: 8Fr 40cc The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall UltraFlex IAB: 7.5Fr 30cc The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall UltraFlex IAB: 7.5Fr 40cc The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall RediGuard IAB: 7Fr 30cc The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Insertion Tray The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Insertion Tray The sheath body may become separated from the sheath hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 16, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Super Arrow-Flex Percutaneous Sheath Introducer Sets Arrow has issued a recall for these products due to potential packaging damage. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200,… Software Issue Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10… Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall iChem VELOCITY Automated Urine Chemistry Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container)… Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 16, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Denali Filter-Jugular/Subclavian Delivery System Bard Peripheral Vascular, Inc. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, 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 Denali Filter-Femoral Delivery System Bard Peripheral Vascular, Inc. Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, 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 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Incorrect femoral component distributed Class IIFDA’s classMar 16, 2016in FDA’s Enforcement ReportKentuckythe one state its words name PublishedMar 16, 2016ClassClass IIStatusTerminatedWhereKentucky
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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