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Encompass Group, LLC

United States US-MF-000008638 Last updated 21 Oct 2026

Devices
14
Registries
EUDAMEDGUDIDFDA 510(k)
FDA recalls
1

Catalogue14

Authorised representatives

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Encompass Group, LLC has one FDA recall record initiated on December 23, 2009, which is marked as terminated. The recall was due to products not being compatible for use in the Magnetic Resonance Imaging (MRI) environment.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2009

    • 23 Dec 2009 Z-1175-2010 Unclassified (pre-2012) Terminated The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

About

Encompass Group is a leading manufacturer and marketer of textiles, apparel, therapeutic support services, and single-use medical products.

From the manufacturer's own website. Source

What Encompass Group, LLC makes

The company manufactures single-use and reusable patient warming solutions, including blankets, gowns, and apparel designed for temperature regulation, such as the Thermoflect Blanket, Thermoflect Patient Gown, and Thermoflect Leggings. It also produces surgical gowns with fluid-resistant properties, like the ROTECNO FR and ROTECNO 2000 models, as well as patient restraints and accessories like pulse oximeter mitts and neonatal swaddling devices. Additional offerings include a patient warming system, the NOVA System, and protective headwear like the Thermoflect Cap.

These products are classified under FDA’s Class I and Class II categories, with some devices listed in the EU’s EUDAMED database and others subject to FDA’s 510(k) clearance process. The company’s devices are regulated under US and EU medical device frameworks, ensuring compliance with applicable safety and performance standards. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States(from SRN)
Address
615, Macon Street, McDonough, United States
Phone
770 626 2172
PRRC contact
Jessica Lester
EUDAMED SRN
US-MF-000008638