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EnsoETM

Advanced Cooling Therapy, LLC · Model ECD05-A · UDI-DI 00857915006128

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510(k) clearances

402

Adverse events (2 deaths)

Recalls

Facilities

Description

The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly.

Recalls

Date	Firm	Reason
2026-02-13	Medline Industries, LP	Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in
2026-02-13	Medline Industries, LP	Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in
2020-11-10	Applied Medical Technology Inc	The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.