FDA Medical devices recall ·
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L… recall
- Recall number
- Z-1506-2026
- Date
- (initiated August 13, 2025)
- Company / brand
- Penner Patient Care, Inc.
101 Grant St, Aurora, NE, United States - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 15 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Why was it recalled?
The device does not bear a unique device identifier.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201
Distribution
US Nationwide distribution.
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-1506-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.