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PLUS

Pressalit A/S · Model R7464 · UDI-DI 05708590360010

INN

510(k) clearances

586

Adverse events (10 deaths)

Recalls

137

Facilities

Description

PLUS shower seat 450, incl. backrest and armrests, orange. Manually height and sideways adjustable, for fitting to horizontal wall track

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.