Medical devices, 2020
Shortlist up to four to read them side by side.
3,055 medical device recalls FDA’s Enforcement Report published in 2020, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,055of 3,055 medical device recallsshown with your filters
The list
- Medical device recall Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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
- Medical device recall Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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
- Medical device recall Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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
- Medical device recall Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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
- Medical device recall Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9 The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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
- Medical device recall Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, 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
- Medical device recall Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for… Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the… The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred… The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Centrella Smart+ Bed The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report38 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report38 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1 The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report38 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Healing Abutment Conical Connection RP 0 3.6 x 5mm Packaged dental implant healing abutments were found to contain the wrong size device. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Michigan, New York and Tennessee named
- Medical device recall Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a… In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, North Dakota, South Carolina and Tennessee named
- Medical device recall Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 10, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ProxiDiagnost N90, UDI 706100 The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an… Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result… Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereArizona, Illinois, Utah and Wisconsin
- Medical device recall System, Tomography Computed Emmission GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report40 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall System, Tomography Computed Emmission GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report40 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall da Vinci SP surgical system Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement Report10 statesnamed in where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereAlabama, Illinois, Maryland, Minnesota, New Jersey, New York, Ohio, Oregon, Tennessee and Texas
- Medical device recall Xhibit Central The firm received reports of loss of audio alarm after a power failure or cable disconnection. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall PerkinElmer 226 Sample Collection Device PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the… Class IIIFDA’s classJun 10, 2020in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 10, 2020ClassClass IIIStatusTerminatedWhereOhio
- Medical device recall Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225. The manufacturer identified a risk that their products might fail to comply with the cabinet x-ray system performance standard limit on x-ray emissions [21 CFR… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Confida Expandable Sheath Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 3, 2020ClassClass IStatusTerminatedWhereAlabama, California, Michigan, New York, Texas and Wisconsin
- Medical device recall Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IStatusOngoingWhereNo state named
- Medical device recall Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Kangaroo Joey Safety Screw Spike Set, Anti-free Flow The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Kangaroo Connect ENPlus Spike Set Anti-free Flow The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Kangaroo Epump Safety Screw Spike Set, Anti-free Flow The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Kangaroo 924 Safety Screw Spike Set The feeding spike sets may leak at the interface of the tube and spike connector. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod… Customers using the firm’s continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and New York, Pennsylvania, Tennessee and West Virginia named
- Medical device recall ARTIS Pheno - Interventional Fluoroscopic X-Ray System If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Skater Introducer Set 6F x 18cm Tungsten coils of the guidewire included in the introducer kit were detaching. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Optilite Optilite Rheumatoid Factor Kit Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report20 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, Florida, Georgia, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New York, Oregon, Pennsylvania, Texas, Vermont, Washington and Wisconsin
- Medical device recall Giraffe Shuttle During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Mississippi, North Carolina, North Dakota, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CooperSurgical Dilator/Sound Set The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report25 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276,… The sensors which activate the safety switches may be affected by delayed activation. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereIllinois and New York
- Medical device recall Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270,… The sensors which activate the safety switches may be affected by delayed activation. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereIllinois and New York
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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