Facility

SHEATHING TECHNOLOGIES, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000135740
Establishment type	Manufacture Medical Device
Location	675 JARVIS DR. MORGAN HILL, CA, US 95037
Registration status	Active · expires 2026
Parent company	SHEATHING TECHNOLOGIES, INC. (owner-operator 9006763)
Brand names	Sheathes

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Radiology-Diagnostic Kit
Product code OIP (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680

Recalls & enforcement

Class IIOngoing2025-11-17
Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk.

FDA inspections (2)

NAI2023-08-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-03-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by SHEATHING TECHNOLOGIES, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SHEATHING TECHNOLOGIES, INC. (FEI 1000135740) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000135740-sheathing-technologies-inc/

Not open yet

Alerts for SHEATHING TECHNOLOGIES, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.