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 Olympus OER-Mini Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained… Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802 Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MAMMOMAT Revelation There were instances where the operator table was sold together with a bus-installation kit. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California and New York named
- Medical device recall MAMMOMAT Inspiration There were instances where the operator table was sold together with a bus-installation kit. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California and New York named
- Medical device recall MAMMOMAT Fusion There were instances where the operator table was sold together with a bus-installation kit. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California and New York named
- Medical device recall Hemochron Activated Clotting Time Low-Range Test Cuvette Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not… Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and West Virginia named
- Medical device recall Incisive CT; Software Version Number: 4.5, 5.0, 5.1 If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CT 5300; Software Version Number: 4.5, 5.0, 5.1 If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841 Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output… An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets… Class IIFDA’s classDec 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedDec 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Illinois, Kentucky, Maryland, Michigan, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia and West Virginia named
- Medical device recall SJM Pericardial Patch, with EnCap Technology 9x14cm The impacted lot may not meet the required tensile strength specification. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall SJM Pericardial Patch, with EnCap Technology 5x10 cm The impacted lot may not meet the required tensile strength specification. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 3, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF… Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV… XXX Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10 The possibility for this product that is intended for demonstration purposes only to be placed in patients. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Delaware, Florida, Idaho, Missouri, Tennessee, Texas, Utah and Virginia named
- Medical device recall DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic… Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report8 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereArizona, California, Connecticut, Florida, Maryland, Mississippi, New York and Pennsylvania
- Medical device recall The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in… Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 Products may contain contamination, which may result in a darker or brown media color. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Virginia, Washington and Wisconsin named
- Medical device recall Quantum Intersegmental Table The heat function may become damaged over time due to patients pressing on the areas with heat function components. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Quantum Intersegmental Table The heat function may become damaged over time due to patients pressing on the areas with heat function components. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Option”ELITE Vena Cava Filter System Due to complaints of increased resistance when advancing the dilator within the introducer sheath. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and 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, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CareLink Clinic Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the… Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FlexLab (FLX) The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous… Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportMichiganthe one state its words name PublishedDec 3, 2025ClassClass IIStatusOngoingWhereMichigan
- Medical device recall FlexLab (FLX) The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous… Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportMichiganthe one state its words name PublishedDec 3, 2025ClassClass IIStatusOngoingWhereMichigan
- Medical device recall Brand Name: Galaxy System Product Name: Galaxy System Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report20 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Idaho, Illinois, Indiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia, Wisconsin, West Virginia and Wyoming
- Medical device recall NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NICO Myriad Illumination Pack Product No Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NICO BrainPath Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BioFire Respiratory Panel 2.1, IVD Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. Class IIFDA’s classDec 3, 2025in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 3, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Idaho, North Carolina, New Hampshire, New Jersey, New York, Oregon, Pennsylvania and South Carolina
- Medical device recall ADDitIV 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 ADDitIV 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 ADDitIV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 Anesthesia IV 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 B.BRAUN 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 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
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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