Facility

Vortex Surgical, Inc.

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

Key facts

3recalls · 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)	3013002167
Establishment type	Manufacture Medical Device
Location	4 Research Park Dr Saint Charles, MO, US 63304
Registration status	Active · expires 2026
Parent company	Vortex Surgical, Inc. (owner-operator 10052162)
Brand names	MAXReach Laser Probe

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (2)

Endoilluminator
Product code MPA (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Photocoagulator And Accessories
Product code HQB (opens in a new tab) · Class II · Ophthalmic · 21 CFR 886.4690

Recalls & enforcement

Class IIOngoing2025-12-16
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Class IIOngoing2025-11-19
Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.
Class IITerminated2023-12-18
Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

FDA inspections (2)

VAI2026-01-08
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2023-02-09
No 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 Vortex 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. “Vortex Surgical, Inc. (FEI 3013002167) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013002167-vortex-surgical-inc/

Not open yet

Alerts for Vortex 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.