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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 71 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR587WDH9201	FDA UDI	Class I	Active
Grafco	2685	FDA UDI	Class I	Active
Lumex	FR597P6705	FDA UDI	Class I	Active
Lumex	FR577RGH6725PA	FDA UDI	Class I	Active
Intensa	IN566DG8567PA	FDA UDI	Class I	Active
Intensa	748B-T3	FDA UDI	Class I	Active
Grafco	2639	FDA UDI	Class I	Active
John Bunn	JB0112-111	FDA UDI	Class II	Active
Intensa	IN601PBL	FDA UDI	Class I	Active
Intensa	460-FS-DW-TL	FDA UDI	Class I	Active
Grafco	1273	FDA UDI	Class I	Active
Intensa	IN577RG401PA	FDA UDI	Class I	Active
Hausted	4600-AQ	FDA UDI	Class I	Active
Lumex	FR587W8604PA	FDA UDI	Class I	Active
Hausted	461EMCST	FDA UDI	Class II	Unknown
Lumex	FR587W1323PA	FDA UDI	Class I	Active
Lumex	FR587WH8516	FDA UDI	Class I	Active
Grafco	3259	FDA UDI	Class I	Active
Lumex	FR566DGH8818	FDA UDI	Class I	Unknown
Everest & Jennings	90763041A	FDA UDI	Class I	Active
Intensa	460-DW-NA	FDA UDI	Class I	Active
Gendron	X-HR-VR-2	FDA UDI	Class I	Active
Intensa	748B-BL-SBCSW	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-SH	FDA UDI	Class I	Active
Intensa	IN587WDOG	FDA UDI	Class I	Active
Lumex	FR597P6724	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRAQUAA	FDA UDI	Class I	Active
Lumex	FR565WG401	FDA UDI	Class I	Active
Intensa	IN587WDH6705PA	FDA UDI	Class I	Active
Lumex	LS900-48	FDA UDI	Class II	Active
Intensa	460-AA-DW-T6	FDA UDI	Class I	Active
Intensa	IN577RGH9214PA	FDA UDI	Class I	Active
Lumex	8220228	FDA UDI	Class I	Active
Everest & Jennings	90763021A	FDA UDI	Class I	Active
Intensa	IN577RG9214PA	FDA UDI	Class I	Active
Intensa	744-T2-SBCSW	FDA UDI	Class I	Active
Intensa	744-DB	FDA UDI	Class I	Active
Lumex	FR566G1319PA	FDA UDI	Class I	Active
Intensa	460-AA-PS-WH	FDA UDI	Class I	Active
Intensa	IN587WH1305	FDA UDI	Class I	Active
Intensa	748CB-WG	FDA UDI	Class I	Active
Intensa	748B-WG	FDA UDI	Class I	Active
Intensa	IN577RGHBL	FDA UDI	Class I	Active
Lumex	FR577RG9214PA	FDA UDI	Class I	Active
Intensa	IN587WDHNOPA	FDA UDI	Class I	Active
Intensa	IN566GHOG	FDA UDI	Class I	Active
Intensa	IN566G8615	FDA UDI	Class I	Active
Intensa	460-FS-DW-PL	FDA UDI	Class I	Active
Intensa	460-PS-GR	FDA UDI	Class I	Active
Intensa	748CB-BT	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.