Z-1506-2026Class III

Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

Name: Z-1506-2026 Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
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 560010-2L, 560010-XL, 560010-1L, 560010-XL 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-1506-2026
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 560010-2L, 560010-XL, 560010-1L, 560010-XL
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: 15 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2026
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)