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Recalls Medical devices 2023

Medical devices, 2023

Shortlist up to four to read them side by side.

2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.

2,477of 2,477 medical device recallsshown with your filters

By the year FDA published them20262,589 20252,908 20243,39420232,47720222,192 20212,303 20203,055 20192,801 20183,757 20172,615 20163,246 20152,495 20143,059 20132,249 20121,310

Filters

FDA’s class Class IClass IIClass III

FDA’s own classes: Class I is the most serious. Each recall’s page quotes FDA’s definition.

Status, in FDA’s file OngoingCompletedTerminated

Where it went, in FDA’s words FDA says nationwideAlabamaAlaskaAmerican SamoaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaGuamHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaNorthern Mariana IslandsOhioOklahomaOregonPennsylvaniaPuerto RicoRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUS Virgin IslandsUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyoming

The states FDA’s words on where the product went name. “Nationwide” is its own choice: to FDA it means the fifty states or a significant portion, so a recall is never counted for a state its words don’t name.

The reason May fail, or give wrong resultsChemicals, metals or drugs that shouldn’t be in itSterility not assuredLabels that are wrong or missingPieces of metal, glass or plasticStrength, purity or how it was madeGerms: Listeria, Salmonella, E. coli and others

Grouped from FDA’s own reason for each recall, which every record shows in full.

Published in FDA’s report

Any

In FDA’s record Class IStill ongoing

The list

Filter by product, brand, reason or number

Order the list NewestNewest firstNameName

Medical device recallsPublishedClassStatusWhere

Medical device recall STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to… The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by… Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall ProPlan CMF Patient-Specific Guide, Mandible guides Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 9, 2023ClassClass IIStatusCompletedWhereNationwide, and Kentucky named
Medical device recall TECNIS Symfony, Extended Range of Vision IOL Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNo state named
Medical device recall TECNIS Eyhance IOL Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNo state named
Medical device recall Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide
Medical device recall Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Class IIFDA’s classAug 9, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 9, 2023ClassClass IIStatusOngoingWhereNationwide

Before these 961 to 1,008 of 2,477 After these

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.”

Medical devices, 2023

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Every line is what FDA’s record says. Recalls aren’t ranked against each other, and a product no recall names isn’t safe by that.

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Hearth Record is independent. It is not a government agency and is not affiliated with, endorsed by or sponsored by CMS, SAMHSA, HRSA, CPSC, NHTSA, FDA, USDA or any state agency. Each fact links to the agency’s own record.

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Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

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State average 14.3

The state average is 14.3.

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CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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