Z-1499-2026 Class III Ongoing
FDA device recall Z-1499-2026 was initiated by Penner Patient Care, Inc. on Aug 13, 2025 and is designated Class III. Reason for recall: The device does not bear a unique device identifier. The recall status is ongoing. Affected quantity: 21 units.
Recall details
- Product Type
- Devices
- Report Date
- Mar 18, 2026
- Initiation Date
- Aug 13, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product description
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Reason for recall
The device does not bear a unique device identifier.
Distribution pattern
US Nationwide distribution.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1499-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026