Facility

DSAART, LLC

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

Key facts

1recalls · worst Class II

3inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	3003897287
Establishment type	Manufacture Medical Device
Location	2950 Arrowhead Drive Carson City, NV, US 89706
Registration status	Active · expires 2026
Parent company	DSAART, LLC (owner-operator 9050953)
Brand names	Silicone sheeting

Activity by year

Recalls (1)
Inspections (3)
Warning letters (1)

Devices registered here (1)

Elastomer, Silicone Block
Product code MIB (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.3620

Recalls & enforcement

Class IIOngoing2025-09-26
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

FDA inspections (3)

OAI2022-10-14
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2021-08-05
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-05-15
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

FDA warning letters (1)

Warning Letter2021-11-24
Warning Letter (opens in a new tab) · Carson City Nevada

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by DSAART, LLC

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. “DSAART, LLC (FEI 3003897287) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003897287-dsaart-llc/

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