FDA Medical devices recall ·
Penner Pacific Bathing Spa, Model Numbers 860010-1L recall
- Recall number
- Z-1508-2026
- 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
- 26 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Penner Pacific Bathing Spa, Model Numbers 860010-1L
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: 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.
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-1508-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.