Z-1505-2026 Class III Ongoing
FDA device recall Z-1505-2026 was initiated by Penner Patient Care, Inc. on Aug 13, 2025 and is designated Class III. Reason for recall: The device does not bear a unique device identifier. The recall status is ongoing. Affected quantity: 25 units.
Recall details
- Product Type
- Devices
- Report Date
- Mar 18, 2026
- Initiation Date
- Aug 13, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product description
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Reason for recall
The device does not bear a unique device identifier.
Distribution pattern
US Nationwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1505-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026