FDA Enforcement
Class III
Ongoing
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Recall: Z-1499-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1499-2026
- 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 350010-1, 350000-2, 350010-X
Reason
The device does not bear a unique device identifier.
Code Info
UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401
Distribution
US Nationwide distribution.
Quantity
21 units