FDA Medical Device Recalls (openFDA)
Turbett Surgical, Inc.: Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Recall number
- Z-1038-2023
- Recalling firm
- Turbett Surgical, Inc.
- Product
- Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Status
- Open, Classified
- Initiated
- 2022-12-05
- Posted
- 2023-01-30
- Terminated
- not on file
- Reason
- Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
- Root cause
- Device Design
- Action
- ***UPDATE*** Turbett Surgical issued via E-mails Product Alert directly to the Hospital departments utilizing the device on 12-27-2022. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Immediately discontinue the use of the specific devices exhibiting one or more failure(s) listed below. " Missing side supports " Broken or cracked side tab support " Backwall weld separation " Side weld separation " Crack in the backwall seam 2. Email (quality@turbettsurgical.com) with the following information. " Hospital name " Serial number(s) " Type of failure that your container exhibited 3. Turbett Surgical will contact you to organize pick up of the damaged unit and shipment of a replacement unit. If your container does not exhibit any of these failures, please continue to monitor and inspect the condition of the container and follow the Instructions For Use (IFU) as you continue utilizing your container. 4. If your container does not exhibit any of these failures, please email quality@turbettsurgical.com stating that your container(s) do not exhibit any of these failures. Please continue to monitor and inspect your devices prior to assembling for sterilization AS WELL AS after sterilization and cooling to ensure expected outcomes. Reminder to follow the Instructions For Use (IFU) as you continue utilizing your TS-1200 container. If you have any questions about the content of this letter, please contact Mark Petras at quality@turbettsurgical.com. ________________________________________________________________________ Turbett Surgical issued Emails to the Hospital department on 12/7/2022. Sales representatives were notified on 12/5/22 to switch out the other container. Letter states reason for recall, health risk and action to take: 1. Immediately verify that the specific serial numbered devices listed below, continues to operate without creating wet loads or the sterilization process is not compromised.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
- Lot, serial or model codes
- GTIN: 00859464007212 Lot Number: All Lot Numbers Serial Number: All Serial Numbers
- 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