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
The list
- Medical device recall Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized… 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 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized… 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 Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized… 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 Burette 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 Burette 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 CARESAFE 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 Caresite 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 Caresite 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 Caresite 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Extension 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 Infusomat 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 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
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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