FDAHealthAugust 13, 2025
Penner Patient Care, Inc. — Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
⚠️ 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 390010-1, 390010-X, 390010-2
- Lot code
- UDI-DI: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
Additional details
UDI-DI: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 25 units.
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