Facility

Think Surgical Inc.

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

Key facts

3recalls · worst Class II

3inspections · 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)	3000719653
Establishment type	Manufacture Medical Device
Location	47201 Lakeview Blvd Fremont, CA, US 94538
Registration status	Active · expires 2026
Parent company	Think Surgical Inc. (owner-operator 10028805)
Brand names	TMINI Miniature Robotic System

Activity by year

Recalls (3)
Inspections (3)

Devices registered here (1)

Orthopedic Stereotaxic Instrument
Product code OLO (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IIOngoing2026-05-08
Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.
Class IIOngoing2024-02-12
There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array gui…
Class IITerminated2018-03-30
There is a potential for the cutter head to detach from the cutter shaft.

FDA inspections (3)

NAI2025-10-23
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2019-08-02
No Action Indicated · Bioresearch Monitoring
NAI2016-01-13
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 Think Surgical 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. “Think Surgical Inc. (FEI 3000719653) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000719653-think-surgical-inc/

Not open yet

Alerts for Think Surgical 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.