Medical devices, 2021
Shortlist up to four to read them side by side.
2,303 medical device recalls FDA’s Enforcement Report published in 2021, 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.
2,303of 2,303 medical device recallsshown with your filters
The list
- Medical device recall 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium,… May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquarius LPH 511-A CRLF2 Distal Probe Green Users may observe very faint additional locus specific signals at 11q13. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Michigan, Minnesota, New Jersey, Texas and Washington
- Medical device recall Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is… Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS) Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New York, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended… GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral… There were customer reports of separation between the tubing and Male Luer Lock Adaptor. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Michigan, Ohio, South Carolina and Texas named
- Medical device recall Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS,… The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, Indiana, Michigan, Minnesota, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic… The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional),… There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way… The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies… Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are… Intermittent potential for shorter than expected clot times. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in… Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IStatusTerminatedWhereNationwide
- Medical device recall VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product… Potential heat and humidity exposure. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Ohio named
- Medical device recall Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual… The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) -… CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FLOW COUPLER Monitor Flow Coupler devices are Potential for the battery to lose its ability to be recharged. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedFeb 10, 2021ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay… Class IIIFDA’s classFeb 10, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedFeb 10, 2021ClassClass IIIStatusTerminatedWhereCalifornia, Florida, Indiana, Kentucky, Maryland, New York, Ohio, Pennsylvania and Texas
- Medical device recall SARS-CoV-2 Antigen Test QIAGEN has become aware of the potential for false positive results to occur with some patient samples. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement Report19 statesnamed in where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereArizona, California, Colorado, District of Columbia, Florida, Hawaii, Illinois, Kentucky, Michigan, Missouri, North Carolina, New Jersey, New Mexico, New York, Ohio, Rhode Island, Texas, Washington and Wyoming
- Medical device recall Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Bottles Missing Product Label Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Optilite Freelite Mx Kappa Free Kit Due to customer complaints of positive bias impacting quality control. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement Report10 statesnamed in where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereColorado, Florida, Iowa, Massachusetts, North Carolina, New Jersey, New York, Ohio, South Dakota and Utah
- Medical device recall Philips EPIQ Diagnostic Ultrasound System The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement Report38 statesnamed in where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Tourni-Cot - Universal, UDI 00855364004085 A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic HVAD Pump Implant Kits, labeled as: a Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IStatusOngoingWhereNationwide
- Medical device recall Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C,… Control panel arm assembly could have missing or loose screws where undue force, pressure or weight is applied, the control panel mechanism can fail and break… Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz Missing Instruction For Use insert. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medical device recall Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36” 90 cm, GS-24 Taper 1/2 40 mm,… Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNew Jersey
- Medical device recall Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by… Harmony RS integrations with Topcon equipment, TRC NW-400 and the Signal Camera, allowed user input of non-unique patient IDs that caused multiple patient… Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereArizona, Missouri, North Carolina, New York, Pennsylvania and Texas
- Medical device recall Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated… Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach Class IIFDA’s classFeb 10, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 10, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO The femoral impactors have a higher than normal risk of the arm breaking. Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PSG-1100 Sleep Diagnostic System Medical device non-conformance to electrical safety standard (IEC 60601-1). Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedFeb 3, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Mexico, New York, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and Washington named
- Medical device recall Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Plus Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Plus Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V60 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 Philips Respironics V680 Ventilator Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored… Class IIFDA’s classFeb 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 54 states named PublishedFeb 3, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, American Samoa, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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
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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