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 STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for… Stat-check CO2 indicators are non-functional. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Missouri, Mississippi, New York, Texas and Wisconsin named
- Medical device recall Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation… There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact… Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Idaho, Kansas, Massachusetts, Michigan, New Hampshire, New Jersey, Nevada, South Carolina, Texas, Utah and Washington
- Medical device recall Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereIndiana, Michigan and Texas
- Medical device recall Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereIndiana, Michigan and Texas
- Medical device recall Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereIndiana, Michigan and Texas
- Medical device recall Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device… Discrepant patient results on Dimension Vista Intelligent Lab Systems. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, 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, 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 Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device… Discrepant patient results on Dimension Vista Intelligent Lab Systems. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, 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, 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 Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup) Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereFlorida, Hawaii, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee and Virginia
- Medical device recall Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup) Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereFlorida, Hawaii, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee and Virginia
- Medical device recall Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereFlorida, Hawaii, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee and Virginia
- Medical device recall Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereFlorida, Hawaii, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee and Virginia
- Medical device recall Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereFlorida, Hawaii, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee and Virginia
- Medical device recall Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereFlorida, Hawaii, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee and Virginia
- Medical device recall Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration… BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, 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 Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication… BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. Class IIFDA’s classJun 8, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 8, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, 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 CytoScan¿ Dx Assay During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment. Class IIIFDA’s classJun 8, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedJun 8, 2016ClassClass IIIStatusTerminatedWhereArkansas, California, District of Columbia, Massachusetts, Michigan, Minnesota, North Carolina, New Mexico, New York, Pennsylvania, South Carolina, Tennessee, Texas, Washington and West Virginia
- Medical device recall ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection… Hummingbird Med Devices, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 1, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedJun 1, 2016ClassClass IStatusTerminatedWhereCalifornia, Georgia, Illinois, Kentucky and Maryland
- Medical device recall 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No.… When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory… Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory… Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WHIN Infusion Set - 90 Huber Needle and Wing Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Mississippi, New Jersey, Nevada, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia
- Medical device recall Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566 Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereAlaska, California, Florida, Georgia, Minnesota, Montana, New Jersey, Ohio, Texas and Washington
- Medical device recall iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment. If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to… Class IIFDA’s classJun 1, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereIllinois and Louisiana
- Medical device recall GE Healthcare, Discovery IGS 730 Potential non-recoverable loss of image acquisition. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Illinois, Indiana, Maryland, Minnesota, Missouri, Mississippi, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall GE Healthcare, Discovery IGS 740 Potential non-recoverable loss of image acquisition. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Illinois, Indiana, Maryland, Minnesota, Missouri, Mississippi, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Mislabeled for size Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNew York
- Medical device recall 3.2 mm Three-fluted drill bit, sterile The sterile packaging may be compromised. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted… The sterile packaging may be compromised. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall SMR glenosphere impactor/extractor Complaints of intra-operative breakage of the glenosphere impactors/extractors. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for… A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. Class IIFDA’s classJun 1, 2016in FDA’s Enforcement Report24 statesnamed in where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee and Washington
- Medical device recall Accriva- APTT Cuvette for use on the Hemochron Jr Clot activating reagent mis-positioned or visibly absent in the cuvette’s test channel causing APTT test to either have an error code or an erroneously high… Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall American Surgical Delicot 15mm x 20mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Delicot 30mm x 70mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/4” x 1/4” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/2” x 1/2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/2” x 1” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/2” x 1.5” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/2” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1” x 3” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 3/8” x 3/4” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/8” x 1/8” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 3/8” x 3/8” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 3/8” x 2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/4” x 1.5” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot White 1.5 cm x 5.5 cm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Americot Blue 1/2” x 2” Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Ultracot 5 mm x 8 mm Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall American Surgical Ultracot 5 mm x 8 mm (Glassine) Product packaging defective compromising sterility Class IIFDA’s classJun 1, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 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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