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 Reprocessed Livewire Steerable Electrophysiology Catheter Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during… Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and… Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Brand Name: Atlan Product Name: Atlan A350 The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia and Wisconsin
- Medical device recall Brand Name: Atlan Product Name: Atlan A350XL The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereAlabama, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia and Wisconsin
- Medical device recall JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT) Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia and Washington named
- Medical device recall Venclose digiRF Generators Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ZAP-X Radiosurgery System If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, New Jersey and New York named
- Medical device recall 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog… a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Biograph mMR There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall BIOGRAPH One (DE) There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Cima.X (DE) There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Connectom.X There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Lumina (DE) There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Prisma There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Skyra (DE) There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Skyra fit There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Skyra Fit BioMatrix There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Spectra as the following: 1 There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Verio There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Verio Dot There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Verio Dot Upgrade There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Vida (DE) There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall MAGNETOM Vida Fit There is a potential for an ice blockage to form or currently exist within the magnet venting system. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) VALVE PACK-LF The kits contain certain lots of cannula products where the catheter may not retain its shape. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 8, 2025ClassClass IStatusOngoingWhereNationwide, and California named
- Medical device recall VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006 Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in… Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois, Montana and Wisconsin named
- Medical device recall Ashvins variant HEYEX 2 / HEYEX PACS Potential that the measured value may be smaller than the actual area. Class IIFDA’s classOct 8, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits labeled as: 1 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 1, 2025in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 1, 2025ClassClass IStatusOngoingWhereAlabama, California, Delaware, Oregon, Tennessee and Texas
- Medical device recall Medline medical convenience kits labeled as: 1 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 1, 2025in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 1, 2025ClassClass IStatusOngoingWhereAlabama, California, Delaware, Oregon, Tennessee and Texas
- Medical device recall Automated Impella Controller (AIC) with the below brands and Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 1, 2025in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 1, 2025ClassClass IStatusOngoingWhereArkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Massachusetts, Michigan, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania and Texas
- Medical device recall Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL.… Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of… Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips CT systems labeled as the following: 1 The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM)… Potential for barb non-engagement. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Mexico, Texas, Virginia, Washington and Wisconsin named
- Medical device recall MyDay Toric, stenfilcon A) Contact Lens One lot manufactured with an invalid sterilization cycle. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, North Carolina and Wisconsin named
- Medical device recall Sofmed Breathables, (stenfilcon A) contact lens One lot manufactured with an invalid sterilization cycle. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, North Carolina and Wisconsin named
- Medical device recall Voyant 1-Day Premium Toric, (stenfilcon A) contact lens One lot manufactured with an invalid sterilization cycle. Class IIFDA’s classOct 1, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 1, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Kentucky, North Carolina and Wisconsin 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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