Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
FDA Recall Z-1499-2026 · Posted 2026-03-09
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Recalling FirmPenner Patient Care, Inc.
Recall StatusOpen, Classified
Product CodeILJ
Date Initiated2025-08-13
Product Quantity21 units
Reason for Recall
The device does not bear a unique device identifier.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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