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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 7 of 91

Device	Model / Reference	Registries	Class	Status
Grafco	3786-12#0	FDA UDI	Class I	Active
Intensa	IN587WDTE	FDA UDI	Class I	Active
Lumex	FR587WDH1304	FDA UDI	Class I	Active
Intensa	IN577RGT5	FDA UDI	Class I	Active
Everest & Jennings	9P835211J	FDA UDI	Class I	Active
Lumex	FR587WD6727PA	FDA UDI	Class I	Active
Lumex	US0218-PKG	FDA UDI	Class II	Active
Hausted	4600-DW-SH	FDA UDI	Class I	Active
Intensa	460-PS-DW-FS-AL	FDA UDI	Class I	Active
Hausted	4200-AL	FDA UDI	Class I	Active
Intensa	748-COM-SBCSW	FDA UDI	Class I	Active
Intensa	IN566G6717	FDA UDI	Class I	Active
Intensa	M368IN577RGHBLPA1	FDA UDI	Class I	Active
Lumex	FR566GH6717	FDA UDI	Class I	Active
Intensa	IN601UHWW	FDA UDI	Class I	Active
Intensa	460-AA-DW-WW	FDA UDI	Class I	Active
Basic American Medical Products	APS986741	FDA UDI	Class II	Active
John Bunn	3255-8	FDA UDI	Class II	Active
Intensa	IN587WH9210PA	FDA UDI	Class I	Active
Intensa	IN587WDH1311	FDA UDI	Class I	Active
Hausted	4600-AA-PU	FDA UDI	Class I	Active
Hausted	6200DA-AR	FDA UDI	Class I	Active
Labtron	425	FDA UDI	Class I	Active
Hausted	4600-AA-PS-VI	FDA UDI	Class I	Active
Intensa	IN587WDHMOPA	FDA UDI	Class I	Active
Grafco	2606	FDA UDI	Class I	Active
Intensa	IN566GH8516PA	FDA UDI	Class I	Active
Intensa	IN566G8516	FDA UDI	Class I	Active
Hausted	4600-PS-BU	FDA UDI	Class I	Active
Hausted	4600-FS-PS-PU	FDA UDI	Class I	Active
Lumex	FM110	FDA UDI	Class II	Active
Lumex	FR597G6714	FDA UDI	Class I	Active
Intensa	420-EO-ST	FDA UDI	Class I	Active
Intensa	IN601PBT	FDA UDI	Class I	Active
Lumex	FR566DG8567PA	FDA UDI	Class I	Active
Everest & Jennings	90763201A	FDA UDI	Class I	Active
Intensa	744CB-PU	FDA UDI	Class I	Active
Lumex	FR597P8604	FDA UDI	Class I	Active
Lumex	FR587WH8567	FDA UDI	Class I	Active
Hausted	4600-AA-NO	FDA UDI	Class I	Active
Intensa	IN587W9201PA	FDA UDI	Class I	Active
Intensa	IN587W9214	FDA UDI	Class I	Active
Intensa	IN577RG6725PA	FDA UDI	Class I	Active
Grafco	1197#3	FDA UDI	Class I	Active
Intensa	748-T1	FDA UDI	Class I	Active
Lumex	FR587WDH409	FDA UDI	Class I	Active
Lumex	FR577RG1315PA	FDA UDI	Class I	Active
Lumex	UMH832	FDA UDI	Class I	Active
Intensa	460-WH	FDA UDI	Class I	Active
Intensa	460-FS-T5	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.