FDA DevicesClass III
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Published: March 18, 2026Recall ID: Z-1499-2026Category: devicesCountry: US
Reason for Recall / Hazard
The device does not bear a unique device identifier.
Product Description & Identification
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Additional Source Details
| Field | Value |
|---|---|
| City | Aurora |
| State | NE |
| Event id | 98396 |
| Address 1 | 101 Grant St |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 68818-3200 |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 21 units |
| Reason for recall | The device does not bear a unique device identifier. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20250813 |
| Initial firm notification | Letter |
| Center classification date | 20260309 |
Overview
- Recalling FirmPenner Patient Care, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide distribution.