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 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT. transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee and West Virginia named
- Medical device recall Glidewell HT Implant Twist Drill ¿1.5 x 8 mm “ Due to packaging mix up. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Kentucky, Massachusetts, Michigan, North Carolina, Virginia and West Virginia named
- Medical device recall ELEOS MALE-FEMALE MIDSECTION 40MM Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Maryland, Missouri, North Carolina and Tennessee named
- Medical device recall Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD… Software issue with scanning equipment that can results in the filed rotation not being applied correctly. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, Florida, Illinois, North Carolina, Virginia and Washington named
- Medical device recall Ultrasonic Cleaning Systems Triton 36 During routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall DORO¿ Easy-Connect Navigation Adaptor Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Idaho, Illinois, Kentucky, Massachusetts, Missouri, North Carolina, New Jersey, New York and Texas named
- Medical device recall Plus Initial Drill, Article Number: 103.170 The referred batch was produced without the laser engraving of 7 mm. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Indiana, Minnesota, North Carolina, Nevada, New York, Ohio, Oklahoma, South Carolina, Texas, Virginia and Wisconsin named
- Medical device recall GM Helix Acqua Implant, Article Number: 140.984 It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah and Wisconsin named
- Medical device recall GM Helix Acqua Implant, Article Number: 140.985 It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah and Wisconsin named
- Medical device recall NxStage PureFlow-B Solution Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when… Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Catalog No. 8888160119 Packaging defect may compromise sterility of the product. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Catalog No. 8888160325 Packaging defect may compromise sterility of the product. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Catalog No. 8888160333 Packaging defect may compromise sterility of the product. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Catalog No. 8888160341 Packaging defect may compromise sterility of the product. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Catalog No. 8888160556 Packaging defect may compromise sterility of the product. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Catalog No. 8888160648 Packaging defect may compromise sterility of the product. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS Chemistry Products CRP Slides Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin, West Virginia and Wyoming named
- Medical device recall BioFire Respiratory Panel 2.1 plus Kit Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental… Potential for breach of Tyvek seals. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Segmental Stem, Cemented, Bowed, 152MM, 1 EACH Potential for breach of Tyvek seals. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH Potential for breach of Tyvek seals. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH Potential for breach of Tyvek seals. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH Potential for breach of Tyvek seals. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Male-Female Midsection with the following sizes and Potential for breach of Tyvek seals. Class IIFDA’s classJun 4, 2025in FDA’s Enforcement Report18 statesnamed in where it went PublishedJun 4, 2025ClassClass IIStatusOngoingWhereArizona, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Nebraska, New Jersey, Ohio, Pennsylvania, Texas, Washington and Wisconsin
- Medical device recall Endopath Echelon Vascular White Reload for Advanced Placement Tip Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Bard Blakemore Esophageal-Nasogastric Tube (Adult) Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Bard¿ Single Intragastric Linton Balloon Tube Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement Report52 statesnamed in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Centerline Biomedical IOPS Guidewire 2 Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement Report8 statesnamed in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereFlorida, North Carolina, New Mexico, New York, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Baxter Novum IQ LVP INFUSION SYSTEM There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the “standby mode” feature or if the device is powered off… FDA Class I, its most serious class Class IFDA’s class (needs attention)May 28, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 28, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall True 3D Viewer With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image… Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Louisiana, Massachusetts, Michigan, Minnesota, New Jersey, Ohio, Pennsylvania and Texas named
- Medical device recall Check=Flo Performer Introducer, 10.0Fr, Reference Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Check=Flo Performer Introducer, 14.0Fr, Reference Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: SmartPath to dStream for 1.5T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: SmartPath to dStream for 3.0T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: SmartPath to dStream for XR and 3.0T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: SmartPath to Ingenia Elition X Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Upgrade to MR 7700 Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Evolution Upgrade 1.5T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Evolution Upgrade 3.0T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Product Name: Ingenia 1.5T Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. Class IIFDA’s classMay 28, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 28, 2025ClassClass IIStatusOngoingWhereNationwide
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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