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 K-201 GUIDE SHEATH KIT 2.0MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-202 GUIDE SHEATH KIT 2.0MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-203 GUIDE SHEATH KIT 2.6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall K-204 GUIDE SHEATH KIT 2.6MM Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-401D-1321 ASPIRATION NEEDLE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-401D-1521 ASPIRATION NEEDLE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-411D-1321 ASPIRATION NEEDLE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-411D-1521 ASPIRATION NEEDLE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-601D-1519 ASPIRATION NEEDLE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PBD-203-0703 BILIARY STENT Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PBD-203-0704 BILIARY STENT Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PBD-203-0707 BILIARY STENT Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PBD-203-0710 BILIARY STENT Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CRESCENT SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CRESCENT SNARE Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Argon Medical Devices TLAB, Transjugular Liver Biopsy System Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Argon Medical Devices TLAB, Transjugular Liver Biopsy System Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Argon Medical Devices TLAB, Transjugular Liver Biopsy System Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Argon Medical Devices TLAB, Transjugular Liver Biopsy System Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Argon Medical Devices TLAB, Transjugular Liver Biopsy System Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Argon Medical Devices TLAB, Transjugular Liver Biopsy System Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending… Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement Report46 statesnamed in where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Covidien ChemoPlus Chemo Spill Kit, Nonsterile Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CHEMOPLUS DRUG SPILL KIT HOS Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ChemoPlus Drug Spill Kit-INSTI Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ChemoPlus” Chemo Prep & Admin Kit, CT4025 Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WAHL 4212 HEATED MASSAGER The connection between the massager and heat element can overheat causing smoke or spark, which may pose a fire hazard Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedFeb 17, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Illinois, Missouri, Pennsylvania, Utah and Wisconsin named
- Medical device recall Gown Isolation W/Ties Univ Ylw There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Gown Isolation W/Ties Xl Ylw There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Gown Isolation W/Ties Univ Blu There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Gown Isolation W/Ties Xl Blue There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Lab Coats SMS Large Blue There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Lab Coats SMS X-Large Blue There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Lab Coats SMS 2X-Large Blue There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Lab Coats SMS Medium White There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Lab Coats SMS Large White There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Lab Coats SMS 2X-Large White There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Gown Kendall Blue RG There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Gown Kendall Blue L There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin and Wyoming named
- Medical device recall Gown Kendall Blue XXL There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. Class IIFDA’s classFeb 17, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedFeb 17, 2021ClassClass IIStatusOngoingWhereNationwide, 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, 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, Washington, Wisconsin 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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