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Allegiance Healthcare Corp.

United StatesFDA applicant, unverified

Devices
64
FDA recalls
1

What Allegiance Healthcare Corp. makes

Allegiance Healthcare Corp. manufactures single-use medical barriers, including nitrile and latex examination gloves, sterile surgical gloves, surgical gowns, drapes, and impervious shoe covers. The company also produces ventilator circuits, breathing circuit filters, and flexible vascular clamps for surgical and critical care settings.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with many products listed via the 510(k) pathway. Allegiance Healthcare Corp. is based in the United States.

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

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FDA recalls1

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

FDA recall records list 1 recall initiated by Allegiance Healthcare Corp., initiated on 2003-01-22. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. 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.

  • 2003

    • 22 Jan 2003 Z-0576-03 Unclassified (pre-2012) Terminated The product labeled as sterile had not been through its sterilzation cycle. Distribution: New Jersey, Georgia, Washington and Florida Submission number: K002419