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U.S. Department of Health and Human Services

Class 3 Device Recall Pacific Bathing Spa

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 Class 3 Device Recall Pacific Bathing Spasee related information
Date Initiated by FirmAugust 13, 2025
Date PostedMarch 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1505-2026
Recall Event ID 98396
510(K)NumberK040772 
Product Classification Bath, hydro-massage - Product Code ILJ
ProductPenner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Code Information UDI-DI: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
Recalling Firm/
Manufacturer		 Penner Patient Care, Inc.
101 Grant St
Aurora NE 68818-3200
For Additional Information ContactKevin Walls
720-254-5756
Manufacturer Reason
for Recall		The device does not bear a unique device identifier.
FDA Determined
Cause 2		Error in labeling
ActionRecall 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 Commerce25 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ILJ
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