Skip to the content

Hearth Record

Places

Assisted living52,260 Child care143,782 Dialysis7,490 Home health19,132 Hospices6,922 Hospitals6,238 Nursing homes14,796 Private schools13,868 Public schools100,212 Health centers

People

Addiction treatment13,432 Mental health treatment14,079 Rehab and long-term care hospitals1,533

Things

All recalls Car seats760 Food29,584 Home products7,058 Kids’ products3,012 Medical devices40,450 Medicines18,075 Pets66 Reports to CPSC70,000 Tires795 Vehicle equipment2,877 Vehicles23,147

Watch list What changed Sign in

All places9 of 13 nationwide Read from public records on Nov 5, 2026 How it works

Recalls Medical devices 2025

Medical devices, 2025

Shortlist up to four to read them side by side.

2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.

FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.

2,908of 2,908 medical device recallsshown with your filters

By the year FDA published them20262,58920252,90820243,394 20232,477 20222,192 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 othersAn allergen not on the label

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 IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named
Medical device recall SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI’s… Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNo state named

Before these 337 to 384 of 2,908 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, 2025

Your shortlist0 of 4

Add one more to compare.

Side by side

The same published facts for each, in the same order, in their sources’ words.

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.

The honest record on the places and things your family relies on.

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.

Every record here is read from the public record and refreshed when its source publishes.

How this record works
Where the facts come from
For providers
Set in Satoshi
Privacy
Terms
Support

↑↓ to moveEnter to openEsc to close

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

This home 11

State average 14.3

The state average is 14.3.

Source:

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

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

1 of 4

Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

2 of 4

A number never stands alone.

Each figure comes with the baseline its source gives, such as the state average or the middle of its neighbours, and the date it describes.

3 of 4

What needs attention is marked.

One color marks what an agency flagged or found most serious. Nothing is colored to look safe: a public record can’t certify safety.

4 of 4

The public record comes first.

Anything a provider adds will sit below the record and say who wrote it. Paying never changes a finding, a rating or the order of results.

Sign in

A free account keeps your watch list, shortlists, comparisons and saved searches on every device, and can email you when something you watch changes. Browsing never needs one.

Continue with Google Continue with Apple

or with your email

Your email

Check your email

We sent a sign-in link to . It works once, in the next 15 minutes. It can take a minute to arrive; if it doesn’t, look in spam.

Free, always. It keeps your email address and what you save, nothing else. Names from Google or Apple are never stored. For adults, 18 and over. Privacy · Terms