FDA Enforcement
Class III
Ongoing
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Recall: Z-1506-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1506-2026
- 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 560010-2L, 560010-XL, 560010-1L, 560010-XL
Reason
The device does not bear a unique device identifier.
Code Info
UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201
Distribution
US Nationwide distribution.
Quantity
15 units