Facility

TURBETT SURGICAL, Inc

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

Key facts

3recalls · worst Class II

4inspections · 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)	3012421755
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	1604 Wayneport Rd Macedon, NY, US 14502
Registration status	Active · expires 2026
Parent company	Turbett Surgical, Inc (owner-operator 10051785)
Brand names	Turbett Surgical Container

Activity by year

Recalls (3)
Inspections (4)

Devices registered here (1)

Wrap, Sterilization
Product code FRG (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6850

Recalls & enforcement

Class IIOngoing2022-12-05
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
Class IITerminated2022-04-14
Devices were subject to unapproved rework processes.
Class IIOngoing2022-04-01
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

FDA inspections (4)

NAI2025-11-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2023-06-26
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-06-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-03-06
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 Turbett 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. “TURBETT SURGICAL, Inc (FEI 3012421755) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012421755-turbett-surgical-inc/

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