FDA Medical devices recall ·
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X recall
- Recall number
- Z-1499-2026
- 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
- 21 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
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: 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.
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-1499-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.