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GF Health Products, Inc

United States·US-MF-000002167

Last updated September 17, 2026

Information

Country: United States
Address: One Graham Field Way, Atlanta, United States
Website: www.grahamfield.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +17703684700
PRRC Contact: Amy Piccini
EUDAMED SRN: US-MF-000002167
FDA FEI Number: 2427360
DUNS Number: —

Catalogue (4538)

Page 14 of 91

Device	Model / Reference	Registries	Class	Status
Health Team	1858	FDA UDI	Class II	Active
Intensa	IN587WDNO	FDA UDI	Class I	Active
Intensa	IN577RG1319	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-SH	FDA UDI	Class I	Active
Intensa	IN597GAR	FDA UDI	Class I	Active
Intensa	7408-CB-PU	FDA UDI	Class I	Active
Intensa	IN566DGH9208PA	FDA UDI	Class I	Active
Everest & Jennings	90763005A	FDA UDI	Class I	Active
Lumex	FR566DGH8628	FDA UDI	Class I	Unknown
Hausted	4600-FS-PS-DO	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-MO	FDA UDI	Class I	Active
Lumex	LF1050	FDA UDI	Class I	Active
Lumex	7109A-2	FDA UDI	Class I	Active
Lumex	FR587WH6705	FDA UDI	Class I	Active
Intensa	610-T1	FDA UDI	Class I	Active
Intensa	460-MO	FDA UDI	Class I	Active
Lumex	FR566DGH6725PA	FDA UDI	Class I	Active
Intensa	IN566DGHOGPA	FDA UDI	Class I	Active
Hausted	4600-FS-PS-NO	FDA UDI	Class I	Active
Intensa	IN587WDHOGPA	FDA UDI	Class I	Active
Hausted	4600-PS-OG	FDA UDI	Class I	Active
Everest & Jennings	24040130	FDA UDI	Class I	Active
Everest & Jennings	8920220	FDA UDI	Class I	Active
Lumex	FR577RGH9201	FDA UDI	Class I	Active
Everest & Jennings	8930220	FDA UDI	Class I	Active
Hausted	4600-FS-DW-PM	FDA UDI	Class I	Active
Intensa	IN577RGAQ	FDA UDI	Class I	Active
Intensa	IN566DG1311	FDA UDI	Class I	Active
Intensa	744-BT	FDA UDI	Class I	Active
Intensa	IN587WDBU	FDA UDI	Class I	Active
Intensa	IN566G432	FDA UDI	Class I	Active
Lumex	FR566G9212PA	FDA UDI	Class I	Active
Intensa	IN577RG8567	FDA UDI	Class I	Active
Lumex	FR601PH8516	FDA UDI	Class I	Active
Intensa	IN566GOG	FDA UDI	Class I	Active
Lumex	FR566GH9212	FDA UDI	Class I	Active
Hausted	4600-FL-WH	FDA UDI	Class I	Active
Lumex	8220248	FDA UDI	Class I	Active
Everest & Jennings	EJ793-1	FDA UDI	Class I	Active
Lumex	FR601PH6724	FDA UDI	Class I	Active
Intensa	460-AA-PS-T10	FDA UDI	Class I	Active
Intensa	460-AA-T5	FDA UDI	Class I	Active
Intensa	IN577RGH409	FDA UDI	Class I	Active
Gendron	G2418-750	FDA UDI	Class I	Active
Intensa	460-FS-AA-T6	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FTPLTA	FDA UDI	Class I	Active
Intensa	460-PS-T3	FDA UDI	Class I	Active
Hausted	4200-ST	FDA UDI	Class I	Active
Intensa	IN566DGH9210PA	FDA UDI	Class I	Active
Grafco	2765	FDA UDI	Class I	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 24, 2021	Z-1353-2021	—	terminated	The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.
Sep 30, 2016	Z-0732-2017	—	terminated	GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported.
Sep 14, 2009	Z-0139-2010	—	terminated	Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.