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Recall Observatory FDA recall evidence

Device product

Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

Z-1505-2026

August 13, 2025

Class III

Product summary

Firm
Penner Patient Care, Inc.
Event
Event 98396
Status
Ongoing
Classification
Class III
Quantity
25 units
Official record key
device-enforcement:Z-1505-2026

Official wording

Reason: The device does not bear a unique device identifier.

Code information: 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

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device does not bear a unique device identifier.