Z-1499-2026 Class III Ongoing

Recalled by Penner Patient Care, Inc. — Aurora, NE

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

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-1499-2026. Report a data issue: hello@regdatalab.com.