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 TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System Potential for missing pins at tip of inserter. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Connecticut named
- Medical device recall FloPatch FP120 Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. Class IIIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IIIStatusOngoingWhereNationwide, and California named
- Medical device recall Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product… Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units… Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover… The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts, North Carolina and Texas named
- Medical device recall Orthopedic Pack Surgical drape packs may have open seals, which may compromise the sterility of the product. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Georgia and Pennsylvania named
- Medical device recall MI Cancer Seek Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNationwide, and New York named
- Medical device recall Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Smiths Medical CADD” Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Smiths Medical CADD” Medication Cassette Reservoir with flow stop, clamp and female Luer Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop,… Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. Class IIFDA’s classSep 10, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 10, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE HealthCare OEC 9800. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GE HealthCare OEC 9900 Elite C-arm Systems. GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Class IIFDA’s classSep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 3, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Battery Operated infusion pumps Insulin pumps manufactured with speakers from Revision A and B may malfunction (“Malfunction 16”) which prevents audible alerts and causes the pumps to become… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 3, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 3, 2025ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall 3D6-2 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 3D9-3v 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 7.5MHZ Endo 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 BP10-5ec 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 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 C10-4ec 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 c5-1 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 C5-2 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 C5-2 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 C6-2 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 C6-3 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 C8-4v 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 C8-4v 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 C8-5 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 C9-2 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 C9-3io 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 C9-3v 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 C9-4 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 C9-4v 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 C9-5ec 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 D2cwc 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 D2TCD 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 D5cwc 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 eL18-4 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 L10-4LAP 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 L11-3 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 L12-3 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 L12-4 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 L12-4 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 L12-5 38mm 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 L12-5 50 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 L15-7io 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 L15-7IO TRANSDUCER 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
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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