BETA
Florida medical device manufacturer and distributor with owned temperature-management, blood-conservation and diagnostic product lines.
3T Medical Systems is a medical device manufacturer and distributor founded in 1998 and headquartered in Apopka, Florida. Led by CEO Jack Kelley and President and COO Ron Frisbie, it combines owned product lines with distribution of third-party medical products.
Its owned businesses include Altrix temperature management, acquired from Stryker in 2025; ConstaVac CBCII blood conservation, acquired from Stryker in 2018; and Enterix diagnostics, acquired in 2022. Enterix’s InSure ONE test is used to detect fecal occult blood as an aid in colorectal screening pathways.
The broader catalog serves hospitals, surgery centers and clinical specialists with anesthesia, surgical and regenerative-medicine products. The company maintains product development, quality and regulatory capabilities alongside its sales and distribution operations.
The owned portfolio includes FDA-cleared Altrix temperature management, ConstaVac CBCII blood conservation and Enterix’s InSure ONE fecal immunochemical test. Their records retain original applicants including Stryker and Enterix; 3T acquired these businesses or product lines in 2018, 2022 and 2025. InSure ONE detects human hemoglobin to aid detection of lower gastrointestinal bleeding; it is not a stand-alone cancer diagnosis. [15][16][14][7][8][12]
FDA lists an open Class II recall, Z-0725-2026, for specified InSure ONE POL kits, models 90010, 90025 and 90030. The affected scope identifies test-card lot TT241102 and kits produced July 23 through September 12, 2025. Sensitivity failure may cause false-negative results. Enterix instructed customers to quarantine affected inventory, notify downstream customers and retest patients tested with affected kits. [21]
Historical records include a terminated 2018 Altrix alarm-related action, terminated 2009 ConstaVac packaging-sterility recalls, and a terminated 2020 InSure ONE test-strip action. These were initiated before 3T acquired the respective lines and concern the configurations and lots identified in each FDA record. [18][20][19]
Latest recorded source review: 2026-11-02.
Scope: selected product families.
| Recalled product / record | Initiated | Source |
|---|---|---|
| September 17, 2025 | [21] |
Documented commercial product families.
Console, circulating-water system and patient-contact wraps for warming, cooling and maintaining a prescribed body temperature. 3T acquired the Altrix product line from Stryker in 2025. [15][17][6]
Commercially available · FDA-cleared product family
Closed disposable system that collects and filters a patient’s blood after surgery for reinfusion. An optional ambulatory bulb supports continued wound drainage. 3T acquired the product line from Stryker in 2018. [13][16][5]
Commercially available · FDA-cleared product family
Enterix test system that qualitatively detects human hemoglobin in fecal samples. Patients collect samples at home using brushes and a test card; laboratory or professional-office processing develops the test. Enterix became part of 3T in 2022. [14][10]
Commercially available · FDA-cleared product familyEnterix initiated an action for specified kits with test-card lot TT241102 due to sensitivity failures. [21]
3T announced acquisition of Altrix temperature management. Site publication followed July 2. [7]
3T acquired Enterix, including its diagnostic products business. [8]
3T acquired the blood conservation product line and announced transfer of manufacturing. [12]
Accessed 11/02/2026
Last substantive review: 11/2/2026