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 Salem Sump PVC Tubes Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 named
- Medical device recall Salem Sump PVC Tubes Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 named
- Medical device recall Salem Sump PVC Tubes Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 named
- Medical device recall Salem Sump PVC Tubes Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 named
- Medical device recall Salem Sump PVC Tubes Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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 named
- Medical device recall BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5 Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5 Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU… Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DxI 9000 Access Immunoassay Analyzer Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Shanghai United Imaging Healthcare Co., Ltd Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall One Step Sterile Lancet for Single Use Due to incorrect/lack of Unique Device Identifier (UDI) codes. Class IIIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 29, 2025ClassClass IIIStatusOngoingWhereNationwide, and Arizona, California, Florida, Illinois, North Carolina, New Mexico, New York, Tennessee, Texas and Virginia named
- Medical device recall iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size… Downstream recall for RES 97605, BioPro femoral components. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and New Jersey, Pennsylvania and Texas named
- Medical device recall LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, New York, Ohio, Tennessee and Texas named
- Medical device recall LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, New Jersey, New Mexico, New York, Ohio, Tennessee and Texas named
- Medical device recall Fuse ULTRA Foot Plating System Instructions for Use Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Louisiana, Nevada, Texas, Washington and Wisconsin named
- Medical device recall MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes… Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD EpiCenter Microbiology Data Management System, labeled as the following: 1 Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Guam and Puerto Rico named
- Medical device recall BD BACTEC Blood Culture System, labeled as the following: 1 Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Guam and Puerto Rico named
- Medical device recall BD BACTEC Blood Culture System, labeled as the following: 1 Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Guam and Puerto Rico named
- Medical device recall BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1 Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Guam and Puerto Rico named
- Medical device recall BD Phoenix M50 Instrument, labeled as the following: 1 Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Guam and Puerto Rico named
- Medical device recall BD Veritor Connect Software, labeled as the following: 1 Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia, Guam and Puerto Rico named
- Medical device recall Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereMissouri and Texas
- Medical device recall Sedecal Mobile Digital Diagnostic X-Ray Systems Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall MobileDiagnost wDR 2.2 Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFX, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KW-FX.899, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS.002, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS.004, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS.005, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS.889, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS-710CW, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number 40KWMOBILE3.899, Mobile X-ray system Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
- Medical device recall Model Number SM-20HF-Batt Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereCalifornia, Illinois and New Jersey
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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