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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 6 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR577RG432PA	FDA UDI	Class I	Active
Hausted	4600-AA-PS-WW	FDA UDI	Class I	Active
Intensa	IN587WD6724	FDA UDI	Class I	Active
Lumex	574G454	FDA UDI	Class I	Active
Intensa	IN566GHBT	FDA UDI	Class I	Active
Gendron	7150P1117	FDA UDI	Class I	Active
Intensa	IN601UPU	FDA UDI	Class I	Active
Intensa	IN587WHSTPA	FDA UDI	Class I	Active
Intensa	460-FS-PS-WG	FDA UDI	Class I	Active
Grafco	3786-12#1	FDA UDI	Class I	Active
Intensa	IN566DG1318	FDA UDI	Class I	Active
Hausted	6200DA-PM	FDA UDI	Class I	Active
Grafco	1196F#4	FDA UDI	Class I	Active
Intensa	IN566DGPMPA	FDA UDI	Class I	Active
Lumex	LF2020-DSLSA3	FDA UDI	Class I	Active
Graham Field	201	FDA UDI	Class II	Active
Everest & Jennings	907633CSE	FDA UDI	Class I	Active
Lumex	FR566DGH8809	FDA UDI	Class I	Unknown
Intensa	IN566GHTL	FDA UDI	Class I	Active
Intensa	460-FS-AA-OG	FDA UDI	Class I	Active
Lumex	FR577RGH1305PA	FDA UDI	Class I	Active
Intensa	IN566G401	FDA UDI	Class I	Active
Intensa	IN601UAQ	FDA UDI	Class I	Active
Everest & Jennings	24040120	FDA UDI	Class I	Active
Everest & Jennings	8920206	FDA UDI	Class I	Active
Intensa	748-TL	FDA UDI	Class I	Active
Hausted	4600-AA-PM	FDA UDI	Class I	Active
Lumex	FR566GH8615PA	FDA UDI	Class I	Active
Intensa	IN587WSTPA	FDA UDI	Class I	Active
Intensa	460-WW	FDA UDI	Class I	Active
Grafco	2744	FDA UDI	Class I	Active
Intensa	IN577RGH8615PA	FDA UDI	Class I	Active
Lumex	FR587WH1311PA	FDA UDI	Class I	Active
Intensa	420-EO-WH	FDA UDI	Class I	Active
Intensa	460-AQ	FDA UDI	Class I	Active
Lumex	FR588W427	FDA UDI	Class I	Active
Intensa	IN566DG9201PA	FDA UDI	Class I	Active
Intensa	IN577RGHTLPA	FDA UDI	Class I	Active
Intensa	460-FS-T9	FDA UDI	Class I	Active
Everest & Jennings	90835202J	FDA UDI	Class I	Active
Intensa	748CB-T3	FDA UDI	Class I	Active
Lumex	FR587WD432PA	FDA UDI	Class I	Active
Hausted	4200-DW-ST	FDA UDI	Class I	Active
Lumex	FR565WG6724	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRRED	FDA UDI	Class I	Active
Intensa	IN587WVIPA	FDA UDI	Class I	Active
Lumex	LCM4880B	FDA UDI	Class II	Active
Intensa	748B-T10	FDA UDI	Class I	Active
Intensa	IN566G6727	FDA UDI	Class I	Active
John Bunn	GF33242	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.