Turbett Surgical, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
FRG	Wrap, Sterilization	Class II	General Hospital	3	2025-04-04

Date	Severity	Status	Recall #	Product	Code	Reason
2022-12-05	Class II	Ongoing	Z-1038-2023	Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthc…	—	Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
2022-12-05	Class II	Ongoing	Z-1037-2023	Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthc…	—	Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
2022-04-14	Class II	Terminated	Z-1501-2022	Turbett Surgical Container, TS1500	—	Devices were subject to unapproved rework processes.
2022-04-01	Class II	Ongoing	Z-1111-2022	Turbett Surgical Container, TS1500	—	Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

Date	K-number	Device	Code	Class	Specialty
2025-04-04	K250011	Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)	FRG	Class II	General Hospital
2021-05-19	K202593	Turbett Instrument Pod	FRG	Class II	General Hospital
2020-04-30	K200240	Turbett Instrument Pod	FRG	Class II	General Hospital

Clearance cadence by quarter