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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1499-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1500-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1501-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1502-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1503-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1504-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1505-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1506-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1507-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1508-2026 | Class III | Ongoing | Voluntary: Firm initiated |
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