FDA Medical Device Recalls (openFDA)
Turbett Surgical, Inc.: Turbett Surgical Container, TS1500
- Recall number
- Z-1501-2022
- Recalling firm
- Turbett Surgical, Inc.
- Product
- Turbett Surgical Container, TS1500
- Status
- Terminated
- Initiated
- 2022-04-14
- Posted
- 2022-08-04
- Terminated
- 2025-02-20
- Reason
- Devices were subject to unapproved rework processes.
- 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 Quality@Turbettsurgical.com. 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
- 7 units
- Distribution
- US Nationwide Nationwide: CO, FL, NC and PA.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K153025"]
- PMA numbers
- not on file
- Product code
- FRG
- Firm FEI
- 3012421755
- Firm city
- Victor
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28