FDA Enforcement
Class III
Ongoing
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Recall: Z-1505-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1505-2026
- Event ID
- 98396
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Penner Patient Care, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 18, 2026
- Initiation Date
- August 13, 2025
- Classification Date
- March 9, 2026
- Address
- 101 Grant St, N/A, Aurora, NE, 68818-3200, United States
Description
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Reason
The device does not bear a unique device identifier.
Code Info
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
US Nationwide distribution.
Quantity
25 units