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 NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0 Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 30, 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 BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01 Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedApr 30, 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 Merit Medical Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Merit Medical Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Amplatzer TorqVue LP Delivery System (TVLP) Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Amplatzer TorqVue LP Catheter (TVLPC) Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall InPen smart insulin pen Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement Report41 statesnamed in where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, 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, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MAGEC 2 Rod, 5.0mm 90mm Standard Devices for the affected lot were not assembled according to product specifications. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas named
- Medical device recall Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in… Due to product outer packaging incorrectly labeled. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Pennsylvania named
- Medical device recall Radiometer ABL90 Series - Radiometer ABL90 FLEX ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement Report48 statesnamed in where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereAlabama, 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, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Philips Brilliance CT Big Bore, Software Version 4.8.0.10430 Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Iowa, Idaho, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Pennsylvania, Tennessee, Texas, Utah, Virginia, Wisconsin and West Virginia named
- Medical device recall Beckman Coulter DxI 9000 Access Immunoassay Analyzer When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The Alinity m System is designed to automate the steps for nucleic acid testing The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R… software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, 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, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: Rover Product Name: Mobile X-ray System Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNew Jersey, Puerto Rico and Washington
- Medical device recall Brand Name: Rover Product Name: Mobile X-ray System Potential for internal fastening mechanism within generator of mobile x-Ray to fail. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNew Jersey, Puerto Rico and Washington
- Medical device recall WB XL Anatomic Healing Abutment XC Incorrect blister labelling. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD 4 Fr Single-Lumen PowerPICC Catheters Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, 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 t:slim X2 Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 23, 2025ClassClass IStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Tandem Mobi Insulin Pump with Interoperable Technology A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 23, 2025ClassClass IStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Hawaii, Iowa, Idaho, Illinois, Indiana, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Ballard Product Name: Closed Suction Catheters Lack of sterility assurance for closed suction catheter systems FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement Report19 statesnamed in where it went PublishedApr 23, 2025ClassClass IStatusOngoingWhereAlabama, California, Connecticut, Florida, Illinois, Kansas, Louisiana, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas and Wisconsin
- Medical device recall MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF:… If “Clear All” selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring… Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Philips DXR System, DuraDiagnost 4.1 Potential for collimator to fall as a result of incorrect installation. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas and Wisconsin named
- Medical device recall Philips DXR System, DuraDiagnost Rel. 4 Potential for collimator to fall as a result of incorrect installation. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Florida, Kansas, Mississippi, New Hampshire, New York, Oregon, Pennsylvania, Texas and Wisconsin named
- Medical device recall Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5… The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue… The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Aveir DR Leadless Pacemaker (LP) Ventricular Device Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, South Carolina and West Virginia named
- Medical device recall Welch Allyn Connex Vital Signs Monitor (CVSM) There were customer reports of devices which experienced battery-related fires. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 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.”
Your shortlist0 of 4
Add one more to compare.