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Erbe USA, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
39
FDA recalls
44 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Erbe USA, Inc. makes

Erbe USA, Inc. manufactures electrosurgical units, including the VIO 300 D and VIO 100 C series with accessories for tissue ablation and coagulation, as well as the ERBEJET 2 system for hydro-jet irrigation. The company also produces cryosurgical units like the ERBECRYO 2, APC applicators for precise tissue treatment, and disposable tubing systems such as the ERBEFLO 2. Additional products include scope port connectors, monopolar attachments, and patient return electrodes for surgical procedures.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database, reflecting their regulatory compliance. Erbe USA, Inc. is based in the United States.

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

Catalogue39

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FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 4 recalls initiated by Erbe USA, Inc., the earliest on 2026-02-12 and the most recent on 2026-06-26. By recorded status: 4 ongoing. The reasons filed fall into these groups: mechanical integrity. 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 0
  • 2024 0
  • 2025 0
  • 2026 4

  • 2026

    • 26 Jun 2026 Z-2938-2026 Class II Ongoing A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture. Distribution: US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California,…
      Full distribution text US Nationwide distribution including in the states and territories of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
      Submission number: K190651
    • 12 Feb 2026 Z-1566-2026 Class I Ongoing Probes may rupture/burst during activation Distribution: US Nationwide distribution, including Puerto Rico. Submission number: K190651
    • 12 Feb 2026 Z-1567-2026 Class I Ongoing Probes may rupture/burst during activation Distribution: US Nationwide distribution, including Puerto Rico. Submission number: K190651
    • 12 Feb 2026 Z-1568-2026 Class I Ongoing Probes may rupture/burst during activation Distribution: US Nationwide distribution, including Puerto Rico. Submission number: K190651

Frequently asked questions

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

The registry currently lists 39 devices for Erbe USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Erbe USA, Inc.'s devices?

Among its 39 most recently registered devices, Erbe USA, Inc. has devices listed in FDA 510(k) (39 devices).

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

Among its 39 most recently registered devices, the classes recorded for Erbe USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Erbe USA, Inc.?

FDA recall records list 4 recalls initiated by Erbe USA, Inc., the most recent initiated on 2026-06-26. 4 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 Erbe USA, Inc. in the registry?

The most recently registered devices listed for Erbe USA, Inc. include ERBE MODEL VIO 300 D WITH ACCESSORIES, ERBOTOM ICC 50, Erbe's Tubing/Cap Sets and ERBECRYO 2 Cryosurgical Unit with accessories.

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