FDA Enforcement
Class III
Ongoing
Penner Pacific Bathing Spa, Model Numbers 860010-1L
Recall: Z-1508-2026
·
Reported March 18, 2026
Enforcement
- Recall Number
- Z-1508-2026
- 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 860010-1L
Reason
The device does not bear a unique device identifier.
Code Info
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
US Nationwide distribution.
Quantity
26 units