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Rusch, Inc.

United StatesFDA applicant, unverified

Devices
26
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Rusch, Inc. makes

Rusch, Inc. manufactures airway management devices, including uncuffed and cuffed tracheal tubes with Magill tips, preformed nasal and oral tracheal tubes, and tracheal bronchial Y stents. Their portfolio also covers silicone and PVC Foley catheters, suprapubic catheterization trays, enteral feeding tubes, and low-profile urinary catheters, designed for respiratory and urological applications.

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

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

Catalogue26

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Rows 1-26 of 26

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 Rusch, Inc., initiated on 2004-02-03. By recorded status: 4 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2004

    • 3 Feb 2004 Z-0578-04 Unclassified (pre-2012) Terminated Valve cap may become loose and enter the air circuitry. Distribution: Nationwide and Canada
    • 3 Feb 2004 Z-0579-04 Unclassified (pre-2012) Terminated Valve cap may become loose and enter the air circuitry. Distribution: Nationwide and Canada
    • 3 Feb 2004 Z-0580-04 Unclassified (pre-2012) Terminated Valve cap may become loose and enter the air circuitry. Distribution: Nationwide and Canada
    • 3 Feb 2004 Z-0581-04 Unclassified (pre-2012) Terminated Valve cap may become loose and enter the air circuitry. Distribution: Nationwide and Canada

Frequently asked questions

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

The registry currently lists 26 devices for Rusch, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Rusch, Inc.'s devices?

Among its 26 most recently registered devices, Rusch, Inc. has devices listed in FDA 510(k) (26 devices).

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

Among its 26 most recently registered devices, the classes recorded for Rusch, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Rusch, Inc.?

FDA recall records list 4 recalls initiated by Rusch, Inc., the most recent initiated on 3 Feb 2004. 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 Rusch, Inc. in the registry?

The most recently registered devices listed for Rusch, Inc. include RUSCH SAFETY CLEAR UNCUFFED WITH MAGILL TIP, RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY, RUSCH TRACHEAL BRONCHIAL Y STENT and RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE.

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