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Gish Biomedical, Inc.

United StatesFDA applicant, unverified

Devices
75
FDA recalls
4

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.

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FDA recalls4

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