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Recall Observatory FDA recall evidence

Device product

Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

Z-1506-2026

August 13, 2025

Class III

Product summary

Firm
Penner Patient Care, Inc.
Event
Event 98396
Status
Ongoing
Classification
Class III
Quantity
15 units
Official record key
device-enforcement:Z-1506-2026

Official wording

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

Code information: UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201

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.