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Recall Observatory FDA recall evidence

Device product

Penner Pacific Bathing Spa, Model Numbers 860010-1L

Z-1508-2026

August 13, 2025

Class III

Product summary

Firm
Penner Patient Care, Inc.
Event
Event 98396
Status
Ongoing
Classification
Class III
Quantity
26 units
Official record key
device-enforcement:Z-1508-2026

Official wording

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

Code information: UDI-DI: 0085007365409; Serial Numbers: 07246737902 10236603401 10226407101 03236488101 03246677601 08226379901 08226385601 12236632601 07226353601 08236572201 04246696501 01256844001 12246811601 06226337201 07236557301 09236582001 02246663101 09246761901 08226369401 08226374601 01246644601 04246691701 08246756001 10236600001 04256958001 04256952001

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.