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Mc3, Inc.

United StatesFDA applicant, unverified FDA FEI 3011468686

Devices
2
Registrations
FDA
FDA recalls
22 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Mc3, Inc. makes

Mc3, Inc. manufactures extracorporeal membrane oxygenation (ECMO) systems, including the Nautilus VF Oxygenator, which supports oxygenation and carbon dioxide removal during cardiopulmonary bypass or ECMO therapy. The company also produces vascular access catheters, such as the MC3 Crescent Jugular Dual Lumen Catheter, designed for central venous cannulation in critical care settings.

The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where Mc3, Inc. is based.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

Company details

FDA FEI number
3011468686
Address
2555 Bishop Circle West, Dexter, MI, 48130

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Mc3, Inc., initiated on 2023-10-11. By recorded status: 2 ongoing. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 2
  • 2024 0
  • 2025 0
  • 2026 0

  • 2023

    • 11 Oct 2023 Z-1309-2024 Class II Ongoing May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer Distribution: US Nationwide distribution. Submission number: K191935
    • 11 Oct 2023 Z-1310-2024 Class II Ongoing May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer Distribution: US Nationwide distribution. Submission number: K191935

Frequently asked questions

How many devices does Mc3, Inc. have in the registry?

The registry currently lists 2 devices for Mc3, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mc3, Inc.'s devices?

Among its 2 most recently registered devices, Mc3, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Mc3, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Mc3, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Mc3, Inc.?

FDA recall records list 2 recalls initiated by Mc3, Inc., the most recent initiated on 11 Oct 2023. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Mc3, Inc. in the registry?

The most recently registered devices listed for Mc3, Inc. include Nautilus VF ECMO Oxygenator and MC3 Crescent Jugular Dual Lumen Catheter.

Generated automatically from registry data and not verified by a human reviewer.