Facility

SYNERGETICS, INC.

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

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)	1000119053
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	3845 Corporate Centre Dr O Fallon, MO, US 63368
Registration status	Active · expires 2026
Parent company	SYNERGETICS, INC. (owner-operator 9005675)

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

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

Recalls & enforcement

Class IOngoing2024-06-12
Sterilization certificates could not be validated by the supplier
Class IITerminated2016-08-11
Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.
Class IITerminated2013-12-09
Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
Class IITerminated2013-07-30
One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.

FDA inspections (2)

VAI2017-11-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act
NAI2016-07-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act

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 SYNERGETICS, 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. “SYNERGETICS, INC. (FEI 1000119053) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000119053-synergetics-inc/

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