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 DreamStation Auto BiPAP Devices may possess a programming error resulting in an incorrect device configuration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania and Texas named
- Medical device recall DreamStation Auto Devices may possess a programming error resulting in an incorrect device configuration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Louisiana, Maryland, Nebraska, New Jersey, New York, Pennsylvania and Texas named
- Medical device recall Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter’s distal end. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Cannulated fenestrated polyaxial screws may be incorrectly labeled Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida and Kentucky named
- Medical device recall Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Cannulated fenestrated polyaxial screws may be incorrectly labeled Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida and Kentucky named
- Medical device recall Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner + Tail Large 4 Long X-Ray… Due to two issues: 1. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long… Due to two issues: 1. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Rolls Gauze Medium 4 Long… Due to two issues: 1. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium… Due to two issues: 1. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Knee implants contain incorrect labeling (size and/or side incorrect) Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, New York, Tennessee and Texas named
- Medical device recall Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Knee implants contain incorrect labeling (size and/or side incorrect) Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Louisiana, New York, Tennessee and Texas named
- Medical device recall Sparrow Ascent Patient Controller, REF’s: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28,… Due to manufacturing issue, neurostimulator device may experience “cable disconnect” error message and interruption to stimulation output. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Prosthesis Head B, 28 mm, 7 mm neck length Inconsistent size terminology and color coding used on labeling Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Louisiana and New Jersey named
- Medical device recall Plastic Trial Head Brown, 7 mm neck length Inconsistent size terminology and color coding used on labeling Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Florida, Indiana, Kansas, Louisiana and New Jersey named
- Medical device recall Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: HeartMate Product Name: Mobile Power Unit Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedAug 20, 2025ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Bartels ELISA Legionella Urinary Antigen Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Maryland and Utah named
- Medical device recall High Pressure Tubing High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Custom Tubing Kit High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Custom Manifold Kit High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Custom Waste Management Kit High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Montana, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall 3mensio Workstation (Vascular Fenestrated) software When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Kansas, Massachusetts, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio and Texas named
- Medical device recall Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 20, 2025ClassClass IIStatusTerminatedWhereNationwide, and Florida, Michigan, Missouri and Texas named
- Medical device recall GE Signa Artist, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Signa Voyager, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA… Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 20, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK… Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow. Class IIIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 20, 2025ClassClass IIIStatusOngoingWhereNationwide, 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 Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Class IIFDA’s classAug 20, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 20, 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.