RegWardenFDA facility compliance records
Recall

Class II — Turbett Surgical, Inc.

Recalling firmTurbett Surgical, Inc
Registered facilityTURBETT SURGICAL, Inc (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonPod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
ProductTurbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Quantity61 units
DistributionUS Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
Initiated2022-12-05
Classified2023-01-30
Recall numberZ-1037-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Turbett Surgical, Inc. (Z-1037-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91314/

Not open yet

Alerts for Turbett 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.