Z-1499-2026Class III

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

Name: Z-1499-2026 Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Creator: Penner Patient Care, Inc.
Published: 2025-08-13
License: https://open.fda.gov/license/

Penner Patient Care, Inc / initiated 2025-08-13 / Open, Classified / root cause: labeling and UDI

FDA source

Penner Patient Care, Inc. began a recall of Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X on 2025-08-13. FDA classified it as Class III and gives the reason as "The device does not bear a unique device identifier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1499-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-08-13
Posted: 2026-03-09
Recalling firm: Penner Patient Care, Inc
Product: Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Product code: ILJ Bath, Hydro-Massage
Reason for recall: The device does not bear a unique device identifier.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Recall notification letters were sent to customers beginning 8/13/25. Your facility has been identified as one that has purchased a Penner Bathing Spa and must place the label(s) attached to this letter(s) next to the current serial tag on your existing Penner Spa and, if applicable, Penner Reservoir. The existing serial tags are located on the side of the spa or reservoir. The serial tag is located behind the TV if you have a Penner Premier Spa with a TV in the cabinet. The last 11 numbers on the UDI label should match the serial number of your existing Penner Spa or Penner Reservoir. Please make sure you attach the corresponding UDI label to the correct Penner product. If you have any questions, please don t hesitate to call our office at 1-800-732-0717.
Quantity in commerce: 21 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1499-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1499-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1500-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1501-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1502-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1503-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1504-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1505-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1506-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1507-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09
Z-1508-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-03-18	2026-03-09

Product code ILJ

K040772Class IIPacific Recumbent Height-Adjustable Bath SystemPenner Manufacturing, Inc. / cleared 2004-04-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)