Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1502-2026Class III

Penner Pacific Bathing Spa, Model Numbers 360020-1P

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

Penner Patient Care, Inc. began a recall of Penner Pacific Bathing Spa, Model Numbers 360020-1P on . FDA classified it as Class III and gives the reason as "The device does not bear a unique device identifier". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1502-2026
Classification
Class III
Status
Open, Classified
Initiated
Posted
Recalling firm
Penner Patient Care, Inc
Product
Penner Pacific Bathing Spa, Model Numbers 360020-1P
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
45 units
Distribution
US Nationwide distribution.
Product codes and lots
UDI-DI: 0085007365403; Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 03256938801

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1502-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1499-2026Class IIIOngoingVoluntary: Firm initiated
Z-1500-2026Class IIIOngoingVoluntary: Firm initiated
Z-1501-2026Class IIIOngoingVoluntary: Firm initiated
Z-1502-2026Class IIIOngoingVoluntary: Firm initiated
Z-1503-2026Class IIIOngoingVoluntary: Firm initiated
Z-1504-2026Class IIIOngoingVoluntary: Firm initiated
Z-1505-2026Class IIIOngoingVoluntary: Firm initiated
Z-1506-2026Class IIIOngoingVoluntary: Firm initiated
Z-1507-2026Class IIIOngoingVoluntary: Firm initiated
Z-1508-2026Class IIIOngoingVoluntary: Firm initiated