Facility

NEOCIS INC

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

Key facts

3recalls · worst Class II

6inspections · worst VAI

—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)	3012787974
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	545 NW 26th St Miami, FL, US 33127
Registration status	Active · expires 2026
Parent company	Neocis (owner-operator 10053750)
Brand names	Yomi Robotic System

Activity by year

Recalls (3)
Inspections (6)

Devices registered here (2)

Dental Stereotaxic Instrument
Product code PLV (opens in a new tab) · Class II · Dental · 21 CFR 872.4120
Dental Navigation System
Product code QRY (opens in a new tab) · Class II · Dental · 21 CFR 872.4120

Recalls & enforcement

Class IITerminated2020-10-30
The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
Class IITerminated2020-05-14
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Class IITerminated2019-10-04
The Fiducial Array may mismatch their measurement files resulting in failed landmark check.

FDA inspections (6)

VAI2024-06-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-08-11
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-08-05
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-02-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2019-12-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-11-02
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.

All facilities operated by Neocis

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. “NEOCIS INC (FEI 3012787974) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012787974-neocis-inc/

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