Skip to content

Sri Surgical

Country not established

Devices
1
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sri Surgical makes

Sri Surgical manufactures the SRI LEVEL II SURGICAL GOWN, a barrier garment designed for use in surgical procedures to protect both patients and healthcare providers from contamination.

The SRI LEVEL II SURGICAL GOWN is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • Sri Level Ii Surgical Gown Ref K090383

    Active Regimes: 510(k) Registry: 510(k) Class:II

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 Sri Surgical, initiated on 2008-07-16. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. 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.

  • 2008

    • 16 Jul 2008 Z-2300-2012 Class II Terminated Distribution of a product that did not meet specifications. (labeling error) Distribution: Nationwide Distribution-including the states of CA, FL, GA, KY, MD, MI, NC, NJ, OK, PA, SC, TN, TX, and UT.

Frequently asked questions

How many devices does Sri Surgical have in the registry?

The registry currently lists 1 device for Sri Surgical. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sri Surgical's devices?

Among its 1 most recently registered device, Sri Surgical has devices listed in FDA 510(k) (1 device).

What risk classes do Sri Surgical's devices fall under?

Among its 1 most recently registered device, the classes recorded for Sri Surgical's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sri Surgical?

FDA recall records list 1 recall initiated by Sri Surgical, the most recent initiated on 16 Jul 2008. 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 Sri Surgical in the registry?

The most recently registered devices listed for Sri Surgical include SRI LEVEL II SURGICAL GOWN.

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