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Harmony Bath

Arjohuntleigh AB · Model AD32801US2001 · UDI-DI 05055982709255

ILJ
10
510(k) clearances
1,022
Adverse events (43 deaths)
10
Recalls
8
Facilities

Description

Bath System - Har Sys23 HM P200+ Des

Recalls

DateFirmReason
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.
2025-08-13Penner Patient Care, Inc.The device does not bear a unique device identifier.

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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.