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 TI Single Vector Distractor Body with Right Foot/20mm DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall TI Single Vector Distractor Body with Left Foot/20mm DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall TI Single Vector Distractor Body with Right Foot/30mm DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall TI Single Vector Distractor Body with Left Foot/30mm DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall TI Single Vector Distractor Proximal Foot/Right DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall TI Single Vector Distractor Proximal Foot/Left DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Florida, Illinois, Massachusetts, Michigan, New Jersey, New York, Pennsylvania, Texas, Utah, Wisconsin and West Virginia named
- Medical device recall OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier Nidek Inc. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Delaware, Georgia, Maine, Missouri, New Mexico, New York, Pennsylvania, Tennessee and Virginia named
- Medical device recall PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip… Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Convenience Kits, MOHS “OPENING” PROCEDURE TRAY Avid Medical Inc. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereMassachusetts and Virginia
- Medical device recall Convenience Kits, MOHS “OPENING” PROCEDURE TRAY Avid Medical Inc. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereMassachusetts and Virginia
- Medical device recall PEDIATRIC KIDNEY BIOPSY TRAY Avid Medical Inc. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereMassachusetts and Virginia
- Medical device recall MAMMOGRAPHY Avid Medical Inc. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereMassachusetts and Virginia
- Medical device recall Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List… Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be… Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 17, 2016ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Iowa, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling… An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language… Class IIIFDA’s classAug 17, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedAug 17, 2016ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Indiana, Michigan, Minnesota, Missouri, New York, Oregon, Pennsylvania, Texas and Washington
- Medical device recall MX 16-slice whole body computed tomography X-ray system The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia
- Medical device recall MX 16-slice SKD whole body computed tomography X-ray system The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia
- Medical device recall STAPLER 45, IS4000 An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 17, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall STAPLER 30, IS4000 An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 17, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall CURVED-TIP STAPLER 30,IS4000 An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 17, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Richard Allan Scientific 10% Neutral Buffered Formalin potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Maryland, New York and Pennsylvania
- Medical device recall VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017,… Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall S3 MedSurg Bed CPU board failures cause fowler (backrest) electronic controls to stop working. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge PACS software When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image),… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall lnvacare Precise Rx Pediatric Flowmeter The rear gradation scale was screen printed upside down on the flowmeter gauge. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report30 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Invacare Precise Rx Pediatric Flowmeter The rear gradation scale was screen printed upside down on the flowmeter gauge. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report30 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the… Software defect causing intermittently slow response of Host. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report46 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall OptraPol Polishing Discs After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Nevada, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Servo Humidifier 163 Cracks may occur at the 15mm and 22mm ISO female connector. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kansas and West Virginia named
- Medical device recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): “NobelGuide… Incorrect drill protocol in the Instructions for Use (IFU) Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Volker 2080, 2082, S 280 and S 282 series beds with lateral release button The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD) Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. Class IIIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 17, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Merge PACS software The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Brilliance 64 CT Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Brilliance iCT Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Brilliance iCT SP Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Ingenuity Core Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the… Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Ingenuity Core128 Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
- Medical device recall Ingenuity CT Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. Class IIFDA’s classAug 17, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedAug 17, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming
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.