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 Servo-u Ventilator System Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Servo-n Ventilator System Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Servo-u MR Ventilator System Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and… In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall interventional fluoroscopic x-ray system In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BiPAP V30 Auto Ventilator This device does not indicate for use in patients with respiratory failure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall BiPAP A30 Ventilators This device does not indicate for use in patients with respiratory failure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall BiPAP A40 Ventilator This device does not indicate for use in patients with respiratory failure. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 9, 2025ClassClass IStatusOngoingWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Brand Name: VITROS Product Name: VITROS 5600 Integrated System A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired… Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: VITROS a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired… Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: VITROS Product Name: VITROS 4600 Chemistry System a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired… Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Identified lots failed incoming quality control testing. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement Report22 statesnamed in where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Wisconsin and West Virginia
- Medical device recall My3D Personalized Solutions Humeral Cup Required inspections were not performed on finished product prior to release and distribution. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland named
- Medical device recall Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN Medline Industries, LP. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Kentucky, Michigan, Texas and Washington named
- Medical device recall Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN Medline Industries, LP. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Kentucky, Michigan, Texas and Washington named
- Medical device recall Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN Medline Industries, LP. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Kentucky, Michigan, Texas and Washington named
- Medical device recall Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular… U.S. Class IIIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 9, 2025ClassClass IIIStatusOngoingWhereNationwide, and Arizona, California, Florida, Illinois, North Dakota, Tennessee and Texas named
- Medical device recall Philips 3D9-3v Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips C5-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips C5-2 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips C9-5EC Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips eL18-4 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips eL18-4 EMT Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips L12-3 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips L12-4 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips L8-4 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips L9-3 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips S5-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips S7-2 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips S7-3t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips S8-3t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips V6-2 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips VL13-5 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips X5-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips X6-1 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips X7-2t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips X8-2t Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips XL14-3 Transducer. Ultrasound transducer devices were refurbished beyond their useful life. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Apex Knee System Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Illinois, Oklahoma, Texas and Utah named
- Medical device recall The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with… Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas named
- Medical device recall Change Healthcare Cardiology Hemo Software Due to complaints, software update may cause software to unexpectedly shutdown. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Florida, Kentucky, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Change Healthcare Cardiology Hemodynamics Software Due to complaints, software update may cause software to unexpectedly shutdown. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, California, Florida, Kentucky, Missouri, Mississippi, Nebraska, New Hampshire, New Jersey, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall VITROS Chemistry Products OP Reagent Gen 15 Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BD Heyman Follower Straight Tip for following sizes: 10Fr Cather packaging may contain the incorrect French size. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall BD Heyman Follower Coude Tip for following sizes: 12Fr Cather packaging may contain the incorrect French size. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia named
- Medical device recall REF: 123400,Bard Urologist’s Tray, For the Obstructed Urethra Cather packaging may contain the incorrect French size. Class IIFDA’s classJul 9, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedJul 9, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and West Virginia 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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