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Wenzellite

Drive Devilbiss Healthcare · Model FC 4029N · UDI-DI 00822383530871

INN

510(k) clearances

590

Adverse events (10 deaths)

Recalls

137

Facilities

Description

Wenzelite Seating & Positioning Product Description Legs w/Casters,FC4000,1 set/bx

Recalls

Date	Firm	Reason
2026-01-05	Raz Design Inc	Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
2022-11-30	Altimate Medical, Inc.	Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.
2021-12-08	R82 A/S	The chrome surface of the push brace can crack during use, potentially cutting the user.
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2015-04-02	Winco Mfg., LLC	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02	Winco Mfg., LLC	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02	Winco Mfg., LLC	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02	Winco Mfg., LLC	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02	Winco Mfg., LLC	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.
2015-04-02	Winco Mfg., LLC	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.