FDA Medical devices recall ·
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 recall
- Recall number
- Z-1505-2026
- 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
- 25 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
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: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
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-1505-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.