Victor, NY, United States
Turbett Surgical, Inc. recalls
3 recalls recorded since 2018, most recently on 5 December 2022. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 December 2022
- 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.
- Distribution
- US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1038-2023, Z-1037-2023
- Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Terminated Class II Medical devices
- Recall started
- 14 April 2022
- Terminated
- 20 February 2025
- Reason
- Devices were subject to unapproved rework processes.
- Distribution
- US Nationwide Nationwide: CO, FL, NC and PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1501-2022
- Turbett Surgical Container, TS1500
Ongoing Class II Medical devices
- Recall started
- 1 April 2022
- Reason
- Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
- Distribution
- Domestic distribution to PA, CA, and NY only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1111-2022
- Turbett Surgical Container, TS1500
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.