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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 64 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR587W8567PA	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-AQ	FDA UDI	Class I	Active
Intensa	IN577RGTLPA	FDA UDI	Class I	Active
Intensa	748-MO	FDA UDI	Class I	Active
Lumex	FR577RGH9207PA	FDA UDI	Class I	Active
Hausted	6200DA-TE	FDA UDI	Class I	Active
Intensa	IN566DGH1304	FDA UDI	Class I	Active
Transfer Master	MLB-TOP-FULL	FDA UDI	Class II	Active
Hausted	4600-AA-PS-ST	FDA UDI	Class I	Active
Intensa	IN587WH9208	FDA UDI	Class I	Active
Transfer Master	MLB-TOP-TWIN	FDA UDI	Class II	Active
Hausted	4200-NA	FDA UDI	Class I	Active
Grafco	1601	FDA UDI	Class II	Active
Intensa	IN577RGHNO	FDA UDI	Class I	Active
Grafco	2628	FDA UDI	Class I	Active
Intensa	IN597G1315	FDA UDI	Class I	Active
Intensa	IN577RGH6714PA	FDA UDI	Class I	Active
Graham Field	201BK-X	FDA UDI	Class II	Active
Hausted	6200-AR	FDA UDI	Class I	Active
Intensa	748-DO	FDA UDI	Class I	Active
Grafco	1303	FDA UDI	Class I	Active
Intensa	744B-SH	FDA UDI	Class I	Active
Everest & Jennings	90763042	FDA UDI	Class I	Active
Intensa	460-PS-DW-GR	FDA UDI	Class I	Active
Intensa	420-EO-DB	FDA UDI	Class I	Active
Lumex	FR587W9214PA	FDA UDI	Class I	Active
Intensa	IN566DGHAQ	FDA UDI	Class I	Active
Intensa	7408-CB-OG	FDA UDI	Class I	Active
Lumex	FR587WDH401	FDA UDI	Class I	Active
Lumex	FR566GH9207PA	FDA UDI	Class I	Active
Lumex	FR566GH8584	FDA UDI	Class I	Active
Hausted	5E8EYEST	FDA UDI	Class II	Unknown
Lumex	6484R-2	FDA UDI	Class I	Active
Intensa	IN587WDH8615	FDA UDI	Class I	Active
Intensa	IN566GWG	FDA UDI	Class I	Active
Intensa	IN577RGHGRPA	FDA UDI	Class I	Active
Intensa	IN577RGHBU	FDA UDI	Class I	Active
Intensa	IN566GSTPA	FDA UDI	Class I	Active
Intensa	744CB-COM	FDA UDI	Class I	Active
Intensa	IN587WD1315	FDA UDI	Class I	Active
Intensa	7408-CB-WW	FDA UDI	Class I	Active
Intensa	IN587W1304	FDA UDI	Class I	Active
Intensa	IN566G9207PA	FDA UDI	Class I	Active
Intensa	IN566DGHALPA	FDA UDI	Class I	Active
Intensa	460-FS-DO	FDA UDI	Class I	Active
Lumex	FR597G8584	FDA UDI	Class I	Active
Basic American Medical Products	LBT717404	FDA UDI	Class II	Active
Lumex	FR566DGH9212PA	FDA UDI	Class I	Active
Grafco	3171	FDA UDI	Class I	Active
Lumex	FR587WH1319	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.