FDAHealthAugust 13, 2025

Penner Patient Care, Inc. — Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

⚠️ The device does not bear a unique device identifier.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: August 13, 2025

US Nationwide distribution.

What's affected?

Product: Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Brand: Penner Patient Care, Inc.
Lot code: UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401

Additional details

UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 21 units.

View original FDA notice →

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