Z-1508-2026Class III

Penner Pacific Bathing Spa, Model Numbers 860010-1L

Name: Z-1508-2026 Penner Pacific Bathing Spa, Model Numbers 860010-1L
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 860010-1L 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-1508-2026
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 860010-1L
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: 26 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 0085007365409; Serial Numbers: 07246737902 10236603401 10226407101 03236488101 03246677601 08226379901 08226385601 12236632601 07226353601 08236572201 04246696501 01256844001 12246811601 06226337201 07236557301 09236582001 02246663101 09246761901 08226369401 08226374601 01246644601 04246691701 08246756001 10236600001 04256958001 04256952001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1508-2026
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)