Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 5, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett” 980 Pediatric Adult Ventilator Puritan… Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used… In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the… There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the… There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich… The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390 There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial,… Inaccurate potassium results may be generated. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereWisconsin
- Medical device recall Dimension Vista 500 Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista 1500 Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02… There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ultra2 Genesys Variants Analyzer lack of 510K Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, Maryland, New Jersey, Utah and West Virginia
- Medical device recall Genesys Analytical Column lack of 510K Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, Maryland, New Jersey, Utah and West Virginia
- Medical device recall Genesys 1 Reagent lack of 510K Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, Maryland, New Jersey, Utah and West Virginia
- Medical device recall Genesys 2 Reagent lack of 510K Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, Maryland, New Jersey, Utah and West Virginia
- Medical device recall Genesys Diluent Reagent lack of 510K Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereArizona, Illinois, Maryland, New Jersey, Utah and West Virginia
- Medical device recall Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in… The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in… The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in… The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual… Cosmetic imperfections on the surface of some lenses. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery… There is a potential for the male connectors on external cables to become damaged. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereFlorida, New York and Utah
- Medical device recall NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Screw is missing from the package Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, New Jersey, New York, Ohio, Pennsylvania, Texas and West Virginia named
- Medical device recall Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a… Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging)… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITEK¿ 2 Systems Software Version 9.01 Update Kit. The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Illinois, Missouri and Texas named
- Medical device recall GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained… RBC Reagent failure. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Georgia, Indiana, North Carolina and Washington named
- Medical device recall Centricity Universal Viewer Zero Footprint Client Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer Compress Devices and Instruments Correction to update the surgical technique for the Compress System. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Theragenics Applicator Needle Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Delaware, Florida, Mississippi, North Carolina, Texas and Utah named
- Medical device recall Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 . Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall IMRIS T2X table Table may drift in the roll position while in use Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMRIS ORT 100 table Table may drift in the roll position while in use Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMRIS ORT 200, Removable Operating Room Table Table may drift in the roll position while in use Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IMRIS ORT 300, Removable Operating Room Table Table may drift in the roll position while in use Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FoundationOne CDx Test Results An incorrect test result for a single analyte may have been reported for up to 800 physician reports Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative,… Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a… Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement… Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a… Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and… Insufficient seal on the sterile barrier of the device, compromising the sterility of the device Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RT-5100 Refractor, a component of the Epic-5100 System. The lens bonding was incomplete on the refractor. Class IIIFDA’s classDec 26, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedDec 26, 2018ClassClass IIIStatusTerminatedWhereFlorida
- Medical device recall 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve) The product was released into commercial distribution while subject to importation refusal. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement Report36 statesnamed in where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
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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