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Recall Observatory FDA recall evidence

Device product

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Z-1501-2026

August 13, 2025

Class III

Product summary

Firm
Penner Patient Care, Inc.
Event
Event 98396
Status
Ongoing
Classification
Class III
Quantity
10 units
Official record key
device-enforcement:Z-1501-2026

Official wording

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

Code information: UDI-DI: 0085007365402; Serial Numbers: 03203147501 01192957001 06203171301 07203175701 11162597701 11193074801 11193074802 09193074801 09193074802 09193074803

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.