Z-1501-2022Class II

Turbett Surgical Container, TS1500

Name: Z-1501-2022 Turbett Surgical Container, TS1500
Creator: Turbett Surgical, Inc.
Published: 2022-04-14
License: https://open.fda.gov/license/

TURBETT SURGICAL, Inc / initiated 2022-04-14 / Terminated / root cause: manufacturing process

FDA source

Turbett Surgical, Inc. began a recall of Turbett Surgical Container, TS1500 on 2022-04-14. FDA classified it as Class II and gives the reason as "Devices were subject to unapproved rework processes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1501-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-14
Posted: 2022-08-04
Terminated: 2025-02-20
Recalling firm: TURBETT SURGICAL, Inc
Product: Turbett Surgical Container, TS1500
Product code: FRG Wrap, Sterilization
Reason for recall: Devices were subject to unapproved rework processes.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm distributed recall notification to hospitals via email on 04/14/2022. The recall notification identifies the reason for recall of specific TS1500 units to be that the repair process employed could restrict the customer's ability to clean and visually check the device for cleanliness. This can be identified by the customer by evidence of bioburden or particulate buildup in the seams of the device. Inadequate or incomplete cleaning of the unit may compromise the sterility of the load. The firm asks customers to immediately discontinue use of the device and complete the provided Return Response Form to [email protected]. Turbett will contact customers to coordinate the replacement of the unit and correction of the recalled device. Customers with any questions can call 585-755-0133x106 from Monday through Friday, from 8:00 AM to 4:30 PM.
Quantity in commerce: 7 units
Distribution: US Nationwide Nationwide: CO, FL, NC and PA.
Product codes and lots: UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001 and 100081/2018031004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1501-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1501-2022	Class II	Terminated	Voluntary: Firm initiated	2022-08-10	2022-08-04

Product code FRG

K153025Class IITurbett Surgical ContainerTurbett Surgical, LLC / cleared 2016-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)