Facility

Seiler Instrument & Mfg. Co.,Inc.

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

Key facts

1recalls · worst Class II

2inspections · 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)	1927430
Establishment type	Manufacture Medical Device
Location	3433 Tree Court Industrial Blvd Saint Louis, MO, US 63122
Registration status	Active · expires 2026
Parent company	Seiler Instrument & Mfg. Co., Inc. (owner-operator 1927430)
Brand names	ALPHA AIR 6 DENTAL; ALPHA AIR 6 ENT; ALPHA AIR 3 DENTAL; ALPHA AIR 3 ENT; 3D Surgical Microscope; Evolution XR6; Seiler IQ; Evolution ZOOM

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Microscope, Surgical
Product code EPT (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4700

Recalls & enforcement

Class IIOngoing2017-01-01
The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.

FDA inspections (2)

NAI2023-10-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-10-19
Voluntary 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 Seiler Instrument & Mfg. Co., 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. “Seiler Instrument & Mfg. Co.,Inc. (FEI 1927430) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1927430-seiler-instrument-mfg-co-inc/

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