Turbett Surgical Container, TS1500 recallZ-1501-2022 · Turbett Surgical, Inc. · initiated Apr 14, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Turbett Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Devices were subject to unapproved rework processes.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1501-2022
- Status
- Terminated
- Initiated by the company
- Apr 14, 2022
- Posted by the FDA
- Aug 4, 2022
- Recalling firm
- Turbett Surgical, Inc.
- Quantity
- 7 units
- Product code
- FRG
- FDA submissions
- K153025
- Distribution
- US Nationwide Nationwide: CO, FL, NC and PA.
Product description
Turbett Surgical Container, TS1500
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Turbett Surgical TS1500Turbett Surgical Inc · Wrap, Sterilization2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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