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Gish Biomedical, Inc.

United StatesFDA applicant, unverified

Devices
75
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Gish Biomedical, Inc. makes

Gish Biomedical, Inc. manufactures single-use medical devices for cardiovascular and thoracic surgical procedures, including vascular access ports, cardioplegia reservoirs, tubing connectors, chest drainage packs, and cardiotomy/autotransfusion systems. Their portfolio also covers blood reservoirs for cardiopulmonary bypass, meconium aspirators, pleural drainage devices, and arterial filters designed for intraoperative use.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions supported via 510(k) clearance. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

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

Catalogue75

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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 Gish Biomedical, Inc., the earliest on 2003-03-31 and the most recent on 2005-11-28. By recorded status: 4 terminated. 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.

  • 2005

    • 28 Nov 2005 Z-0519-06 Unclassified (pre-2012) Terminated Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported. Distribution: Nationwide (CA, FL, IL, IN, MA, MI, MS, NH, NJ, NY, OH, PA, WI, VA), Canada, and Mexico. Submission number: K023381
    • 28 Nov 2005 Z-0575-06 Unclassified (pre-2012) Terminated The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks. Distribution: CA, FL, IN, MA, MI, NJ, NY Submission number: K040355

  • 2004

    • 4 Mar 2004 Z-0730-04 Unclassified (pre-2012) Terminated Customers reported leakage. Distribution: NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA Submission number: K023381

  • 2003

    • 31 Mar 2003 Z-0780-03 Unclassified (pre-2012) Terminated Two reports of leakage. Distribution: Nationwide, Austria, Canada, Japan, Saudi Arabia Submission number: K961530

Frequently asked questions

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

The registry currently lists 75 devices for Gish Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gish Biomedical, Inc.'s devices?

Among its 50 most recently registered devices, Gish Biomedical, Inc. has devices listed in FDA 510(k) (50 devices).

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

Among its 50 most recently registered devices, the classes recorded for Gish Biomedical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Gish Biomedical, Inc.?

FDA recall records list 4 recalls initiated by Gish Biomedical, Inc., the most recent initiated on 28 Nov 2005. 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 Gish Biomedical, Inc. in the registry?

The most recently registered devices listed for Gish Biomedical, Inc. include VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER, CPS-3000 CARDIOPLEGIA RESERVOIR, TUBING CONNECTORS EC-2XXX SERIES and CHEST DRAINAGE PACK, CDP-1000.

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