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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 36 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR566DGH8602PA	FDA UDI	Class I	Active
Intensa	744-T10	FDA UDI	Class I	Active
Grafco	3214	FDA UDI	Class I	Active
Grafco	1565 4	FDA UDI	Class I	Active
Intensa	IN587WDDBPA	FDA UDI	Class I	Active
Intensa	460-FS-AA-T8	FDA UDI	Class I	Active
Labtron	202GY	FDA UDI	Class II	Active
Intensa	460-FS-AA-T10	FDA UDI	Class I	Active
Intensa	IN587WD6724PA	FDA UDI	Class I	Active
Basic American Medical Products	ZZA9917448	FDA UDI	Class II	Active
Intensa	IN587WDHWW	FDA UDI	Class I	Active
Intensa	IN587WH9201PA	FDA UDI	Class I	Active
Intensa	IN577RGBU	FDA UDI	Class I	Active
Intensa	IN566GDOPA	FDA UDI	Class I	Active
Intensa	IN601PPL	FDA UDI	Class I	Active
Intensa	IN597G8626	FDA UDI	Class I	Active
Intensa	IN566DGHDOPA	FDA UDI	Class I	Active
Intensa	748B-BL	FDA UDI	Class I	Active
Intensa	IN566DGHMO	FDA UDI	Class I	Active
Lumex	FR601UH1325	FDA UDI	Class I	Active
Hausted	4600-ST	FDA UDI	Class I	Active
Grafco	3853	FDA UDI	Class I	Active
Intensa	IN577RGH1319	FDA UDI	Class I	Active
Intensa	IN566GMOPA	FDA UDI	Class I	Active
Intensa	748CB-T4	FDA UDI	Class I	Active
Intensa	460-FS-AA-AQ	FDA UDI	Class I	Active
Intensa	IN566DG1319	FDA UDI	Class I	Active
Grafco	C101	FDA UDI	Class I	Active
Grafco	2732	FDA UDI	Class I	Active
Grafco	2671	FDA UDI	Class I	Active
Lumex	FR566DF409	FDA UDI	Class I	Active
Hausted	4600-FS-DW-GR	FDA UDI	Class I	Active
LUMEX Essentials	81166	FDA UDI	Class I	Active
Intensa	IN587WHVI	FDA UDI	Class I	Active
Everest & Jennings	3J010530	FDA UDI	Class I	Active
Everest & Jennings	5PX10620	FDA UDI	Class I	Active
Everest & Jennings	3K010330	FDA UDI	Class I	Active
Lumex	FR587WH401PA	FDA UDI	Class I	Active
Intensa	460-AA-DW-OG	FDA UDI	Class I	Active
Lumex	FR597G1315	FDA UDI	Class I	Active
Everest & Jennings	8565166	FDA UDI	Class I	Active
Intensa	7408-B-ST	FDA UDI	Class I	Active
Intensa	IN566DG9207	FDA UDI	Class I	Active
Intensa	IN601PHWW	FDA UDI	Class I	Active
Intensa	IN587W1311	FDA UDI	Class I	Active
Everest & Jennings	9B007700J	FDA UDI	Class I	Active
LabTron	202X	FDA UDI	Class II	Active
Intensa	IN566DG9212	FDA UDI	Class I	Active
John Bunn	S131	FDA UDI	Class II	Active
Hausted	6200DA-BU	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.