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 GE Healthcare CARESTATION 750 A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 750 A2 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 750c A1 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare CARESTATION 750c A2 Certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 7, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall The Trimble RTS873 robotic total station is a solution designed for construction professionals seeking… An issue has been identified in the production of the RTS873 robotic total stations that may result in the green aiming laser output power being above its… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall DxC 500 AU Clinical Chemistry Analyzer The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Georgia, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Mexico, Nevada, New York, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Illinois, Kansas, Michigan, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina and Wisconsin named
- Medical device recall Hyperthermia Pump Procedure Kit Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, North Carolina, North Dakota, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Straight Inflow/Outflow Patient Line Kit Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, North Carolina, North Dakota, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Straight Inflow/Bifurcated Outflow Line Kit Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, District of Columbia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, North Carolina, North Dakota, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall 3.0 Liter Disposable Set Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall HistoCore PELORIS 3 There is a leakage issue associated with the tubing in the manifold of the instrument. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report14 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereArizona, California, Florida, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall epoc BGEM BUN Test Card The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall epoc BGEM Crea Test Card The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IceSeed 1.5 CX NEEDLE US, Cryoablation Needle Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Semi-Automated External Defibrillators It was noticed there was no Italian translation included for the AED. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Automated External Defibrillators It was noticed there was no Italian translation included for the AED. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Automated External Defibrillators It was noticed there was no Italian translation included for the AED. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Automated External Defibrillators It was noticed there was no Italian translation included for the AED. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Automated External Defibrillators It was noticed there was no Italian translation included for the AED. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia… Medical device software marketed without FDA clearance . Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report38 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without… Medical device software marketed without FDA clearance . Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report38 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Distal Femoral Augment The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia and Wisconsin named
- Medical device recall Posterior Femoral Augment The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia and Wisconsin named
- Medical device recall L-Shaped Femoral Augment The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia and Wisconsin named
- Medical device recall Tibial Augment The device was delivered with a preassembled Femoral Augment screw that was missing its thread. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Missouri, Nevada, Ohio, Texas, Virginia and Wisconsin named
- Medical device recall myQA iON; Article Number: MQ10-000 Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Florida, Georgia, Kansas, Maryland and Oklahoma named
- Medical device recall Enhanced Verify Evaluation Handset (CFN HH90130FA) Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Medline Sterile Water, USP, 100mL It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Sterile 0.9% Normal Saline, USP, 100mL It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: T AND A PACK -LF It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: NON STERILE I&D KIT It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: 1) STERILE PREP KIT It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: PLASTICS SUTURE TRAY It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: 1) WOUND CARE TRAY It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: REDDY JOINT BATH It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: OL OCULAR It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits, labeled as: HAND It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Preset treatment parameters are not consistently being used in accordance with the IFU. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during… A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. 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 Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during… A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. 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 Veradius Unity A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. 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 Zenition 70. The device is to be used in health care facilities both inside and outside the operating room,… Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Due to manufacturing issues there is a potential for the catheter sheath to detach. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 30, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 30, 2025ClassClass IStatusOngoingWhereGeorgia, New Jersey, New York and Ohio
- Medical device recall The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm… There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 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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