Facility

KATALYST SURGICAL, LLC

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

Key facts

1recalls · worst Class II

3inspections · 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)	3007589150
Establishment type	Remanufacture Medical Device; Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device
Location	722 Goddard Ave Chesterfield, MO, US 63005
Registration status	Active · expires 2026
Parent company	Katalyst Surgical, LLC (owner-operator 10029103)
Brand names	McPherson Tying Forceps; Monarch II IOL Injector; Hersh LASIK Retreatment Forceps; Akahoshi Prechopper Cross-action; Reverse Utrata Forceps; Jeweler Forceps; O'Gawa-Utrata Capsulorhexis Forceps; Landers Lens Forceps; Maumenee Forceps; Gianneti Capsulorhexis Forceps; Thorpe Fixation Forceps; Putterman Clamp

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Forceps, Ophthalmic
Product code HNR (opens in a new tab) · Class I · Ophthalmic · 21 CFR 886.4350

Recalls & enforcement

Class IIOngoing2026-03-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.

FDA inspections (3)

VAI2025-07-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-08-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-03-15
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · 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 Katalyst Surgical, 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. “KATALYST SURGICAL, LLC (FEI 3007589150) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007589150-katalyst-surgical-llc/

Not open yet

Alerts for KATALYST SURGICAL, LLC

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.