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Companies / Turbett Surgical
Medical device company profile

Turbett Surgical

Reusable multi-tray containers for surgical instrument sterilization, storage and operating-room delivery.

Medical Device ManufacturerGeneral Medical & Patient CareSurgery & Procedural CareSterilization & Infection PreventionSurgical InstrumentsCommercial-stage
HeadquartersπŸ‡ΊπŸ‡ΈMacedon, New York, United States
FoundedNot confirmed
Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.
EmployeesNot confirmed
Estimated revenueNot confirmed
Official websiteturbettsurgical.com β†—

Company overview

Turbett Surgical manufactures instrument-processing containers for hospitals and ambulatory surgery centers. Its Pod products accommodate multiple instrument trays and are intended for compatible pre-vacuum steam sterilization, followed by storage and transport to the operating room. Current models include TS1500, TS1200 and TS1000.

The company identifies its headquarters and engineering facilities in Macedon, New York, with a further location in Braintree, Massachusetts. Its commercial approach includes regional representatives and clinical specialists supporting workflow assessment, staff preparation and implementation.

FDA records distinguish the newer 2025 Instrument Pod clearance from earlier TS1500 containers. Two reviewed 2022 recall events concerned weld failures and rework processes in specified older units. One record remains listed as open and the other is terminated; neither is silently generalized to all current Pods.

[15][19]

Leadership

1 people
Kevin DanahyPresident & Chief Executive Officer [19]

Products & regulatory status How does MedTechIndex get this information?

Summary

The current Instrument Pod decision K250011 is distinct from earlier Turbett container authorizations. FDA recall records cover specified legacy containers, including TS1000 and TS1200 as well as TS1500-related history; model names alone do not show that every current production unit is affected. [15][16][17][18][5][1]

The matched FDA history contains 3 distinct recall events: 2 open, 1 terminated. Z-1037-2023 (2022-12-05; 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. Z-1111-2022 (2022-04-01; open, classified): Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. [11][12][9]

Regulatory snapshot How to read this snapshot

U.S. FDA
1
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

View 2 documented open recall events

Includes open events outside the mapped current portfolio; those events are excluded from the snapshot count.

Documented open FDA recall events
Recalled product / recordInitiatedSource
  • Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare providerZ-1037-2023
  • Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare providerZ-1038-2023
December 5, 2022[11][12]
  • Turbett Surgical Container, TS1500Z-1111-2022
April 1, 2022[9][17]

Commercial portfolio snapshot

Documented commercial product families.

Reusable sterilization container

Instrument Pod TS1500 / TS1200 / TS1000 β†—

Multi-tray container family for compatible steam sterilization, subsequent storage and delivery. [15][16]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Products with unconfirmed commercial availability

Legacy sterilization container

Legacy TS1500 surgical containers β†—

Earlier TS1500 units associated with K153025 and specified 2022 recalls; current availability not established. [15]

Commercial availability not established

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Activity & Milestones

2 events
2026-05-06 Β· Leadership

Kevin Danahy appointed President and CEO

Company appointment announcement identifies Danahy as President and Chief Executive Officer. [19]

2025-04-04 Β· Regulatory

Updated Instrument Pods cleared

FDA cleared three Instrument Pod models under K250011. [16]

19 Cited Sources

Accessed 10/20/2026

[1] FDA 510(k) database β€” research search β†—FDA / openFDA Β· regulatory record
[2] FDA K153025 β€” Turbett Surgical Container β†—U.S. Food and Drug Administration Β· regulatory record
[3] FDA K200240 β€” Turbett Instrument Pod β†—U.S. Food and Drug Administration Β· regulatory record
[4] FDA K202593 β€” Turbett Instrument Pod β†—U.S. Food and Drug Administration Β· regulatory record
[6] FDA De Novo database β€” research search β†—FDA / openFDA Β· regulatory record
[8] FDA PMA database β€” research search β†—FDA / openFDA Β· regulatory record
[9] FDA recall Z-1111-2022 β€” TURBETT SURGICAL, LLC β†—U.S. Food and Drug Administration Β· regulatory record
[10] FDA recall Z-1501-2022 β€” Turbett Surgical, Inc. β†—U.S. Food and Drug Administration Β· regulatory record
[11] FDA recall Z-1037-2023 β€” Turbett Surgical, Inc. β†—U.S. Food and Drug Administration Β· regulatory record
[12] FDA recall Z-1038-2023 β€” Turbett Surgical, Inc. β†—U.S. Food and Drug Administration Β· regulatory record
[14] FDA UDI database β€” research search β†—FDA / openFDA Β· regulatory record
[16] FDA 510(k) K250011 β†—U.S. Food and Drug Administration Β· regulatory database
[17] FDA recall Z-1111-2022 β†—U.S. Food and Drug Administration Β· regulatory database
[18] FDA recall Z-1501-2022 β†—U.S. Food and Drug Administration Β· regulatory database
[19] Kevin Danahy appointment announcement β†—Turbett Surgical via Business Wire Β· company press release Β· Published 2026-05-06
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