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 L17-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall L18-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall L8-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall L9-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall mC12-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall mC7-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Mini Multi TEE Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall mL26-8 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall OMNI II TEE Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall OMNI III TEE Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S12-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S3-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S4-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S4-1 Lumify Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S4-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S5-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S7-3t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S7-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S8-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S8-3t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall S9-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall SCNHD LA L7-4 HDI Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Transducer C10-3v Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall TRANSDUCER L12-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall V6-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall V9-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall VL13-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X11-4t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X3-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X5-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X5-1c Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X6-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X7-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X7-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall X8-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall XL14-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Class IIIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Spectrum IQ Infusion Pump Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereArizona and Florida
- Medical device recall Brand Name: THOR Product Name: NovoTHOR The potential for a failed welded nut to shear off. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Massachusetts, Maryland, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: THOR Product Name: NovoTHOR XL The potential for a failed welded nut to shear off. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Massachusetts, Maryland, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX The potential for a failed welded nut to shear off. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Massachusetts, Maryland, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX The potential for a failed welded nut to shear off. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Massachusetts, Maryland, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Corin Operating Tables Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment,… Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Kentucky, New York and Texas named
- Medical device recall Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois, Louisiana, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia named
- Medical device recall Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Illinois, Louisiana, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, Texas and West Virginia named
- Medical device recall ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall PrisMax V2-US, Hemodialysis Delivery System Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNo state 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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