Is this your brand? Sign in to claim ownership.
Sign in to claim this brandTurbett Surgical, LLC
US
Last updated May 23, 2026
What Turbett Surgical, LLC makes
Turbett Surgical, LLC manufactures reusable device sterilization and disinfection containers designed for surgical instruments and medical equipment. These containers are engineered to protect items during cleaning, sterilization, and storage processes in clinical settings.
The company’s products fall under FDA Class II regulation and are listed via 510(k) and UDI compliance. The portfolio is authorised for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Turbett Surgical, LLC manufacture?
Turbett Surgical, LLC specializes in reusable device sterilization and disinfection containers. These containers are specifically designed to safeguard surgical instruments and medical equipment during cleaning, sterilization, and storage in healthcare environments. The focus is on ensuring the integrity and safety of instruments throughout these critical processes.
Where is Turbett Surgical, LLC based, and where are its devices authorised for use?
Turbett Surgical, LLC is headquartered in the United States. The company’s devices are authorised for use in the US market, where they undergo regulatory compliance processes to ensure safety and effectiveness.
How are Turbett Surgical, LLC’s devices classified by the FDA, and why?
Turbett Surgical, LLC’s devices fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and performance. The company’s sterilization and disinfection containers are regulated under these controls to maintain rigorous standards for reusable medical equipment protection.
Which regulatory registries or databases list Turbett Surgical, LLC’s devices?
Turbett Surgical, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and comply with Unique Device Identifier (UDI) requirements. These registries ensure transparency and traceability of medical devices in the US market, helping healthcare providers and regulators verify compliance and device details.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (34)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Turbett Surgical | TS3025 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2044 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3044 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3015 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2011 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2055 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3020 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3035 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3080 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2037 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2053 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2030 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2020 | FDA UDI | Class II | Active |
| Turbett Surgical | TS1500 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2036 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2056 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2052 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2051 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2038 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2039 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2047 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2025 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3085 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3070 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2045 | FDA UDI | Class II | Active |
| Turbett Surgical | TS1200 | FDA UDI | Class II | Active |
| Turbett Surgical | TS1000 | FDA UDI | Class II | Active |
| Turbett Surgical | TS2015 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3041 | FDA UDI | Class II | Active |
| Turbett Surgical | TS3010 | FDA UDI | Class II | Active |
| Turbett Instrument Pod | K200240 | FDA 510(k) | Class II | Active |
| Turbett Instrument Pod | K202593 | FDA 510(k) | Class II | Active |
| Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | K250011 | FDA 510(k) | Class II | Active |
| Turbett Surgical Container | K153025 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Turbett Surgical, LLC has four FDA recall records initiated between April 1, 2022, and December 5, 2022. The records include devices subject to unapproved rework processes, with one instance involving eight units manufactured before June 2019 that exhibited weld failures compromising the sterile barrier after prolonged use. Additional concerns noted potential weld failures in another product line, which could breach sterility and lead to contamination. The recalls are documented with statuses of open, classified, and terminated.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 5, 2022 | Z-1037-2023 | — | open, classified | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| Dec 5, 2022 | Z-1038-2023 | — | open, classified | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| Apr 14, 2022 | Z-1501-2022 | — | terminated | Devices were subject to unapproved rework processes. |
| Apr 1, 2022 | Z-1111-2022 | — | open, classified | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. |