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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 57 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	420-DW-COM	FDA UDI	Class I	Active
Intensa	420-T2	FDA UDI	Class I	Active
Grafco	2749	FDA UDI	Class I	Active
Gendron	GS4842DNS	FDA UDI	Class II	Active
Lumex	FR565WG8801	FDA UDI	Class I	Active
Hausted	6200-DO	FDA UDI	Class I	Active
Lumex	LF1030MS	FDA UDI	Class I	Active
Everest & Jennings	EJ784-1	FDA UDI	Class I	Active
Hausted	5E8EYXST	FDA UDI	Class II	Unknown
Lumex	FR566DG6714PA	FDA UDI	Class I	Active
Labtron	602LB	FDA UDI	Class I	Active
Hausted	4600-FS-DW-NA	FDA UDI	Class I	Active
Hausted	4600-FS-PS-WH	FDA UDI	Class I	Active
Everest & Jennings	EJ782-1	FDA UDI	Class I	Active
Everest & Jennings	8565228	FDA UDI	Class I	Active
Lumex	FR566G1305PA	FDA UDI	Class I	Active
Lumex	FR587WH9212PA	FDA UDI	Class I	Active
Intensa	IN587WTL	FDA UDI	Class I	Active
Lumex	FR577RGH9212PA	FDA UDI	Class I	Active
Intensa	460-FL-DO	FDA UDI	Class I	Active
Intensa	460-FS-VI	FDA UDI	Class I	Active
Grafco	2859	FDA UDI	Class I	Active
Grafco	4002GF	FDA UDI	Class II	Active
Intensa	IN587W1315	FDA UDI	Class I	Active
Intensa	748B-T7	FDA UDI	Class I	Active
Intensa	IN566DGH8602	FDA UDI	Class I	Active
Hausted	4600-FS-DW-PU	FDA UDI	Class I	Active
Hausted	4600-TL	FDA UDI	Class I	Active
Intensa	IN587WD1305	FDA UDI	Class I	Active
Intensa	IN577RGH8567	FDA UDI	Class I	Active
Intensa	IN587WD9212PA	FDA UDI	Class I	Active
Grafco	3786-12#4	FDA UDI	Class I	Active
Everest & Jennings	EJ781-1	FDA UDI	Class I	Active
Lumex	FR587WD8604PA	FDA UDI	Class I	Active
Transfer Master	B311-Q	FDA UDI	Class II	Active
Intensa	IN587WGR	FDA UDI	Class I	Active
Intensa	744CB-GR	FDA UDI	Class I	Active
John Bunn	1398-1#6	FDA UDI	Class II	Active
Intensa	IN566GHDBPA	FDA UDI	Class I	Active
Everest & Jennings	3F020320	FDA UDI	Class I	Active
Lumex	12-1001	FDA UDI	Class I	Active
Lumex	DSHC70011	FDA UDI	Class I	Active
Everest & Jennings	EJ78-HANDLESA	FDA UDI	Class I	Active
Grafco	2862	FDA UDI	Class I	Active
Lumex	FR565DG857	FDA UDI	Class I	Active
Everest & Jennings	3F030140	FDA UDI	Class I	Active
Intensa	IN587WDHWG	FDA UDI	Class I	Active
Gendron	G3020-750	FDA UDI	Class I	Active
Intensa	IN587WAQ	FDA UDI	Class I	Active
Lumex	FR587W9208PA	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.