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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-1503-2026
Recall Event ID 98396
510(K)NumberK040772 
Product Classification Bath, hydro-massage - Product Code ILJ
ProductPenner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
Code Information UDI-DI: 0085007365404; Serial Numbers: 02216037601 03246681301 11193096501 07216136901 07216138701 02256869801 03246682501 11182940901 11193101101 03226290001 03226290002 01162459901 01203113001 01203113002 01203113003 07203175801 07203175801 01226258801 10226408401 03203144501 11246797902 09226392901 05246713601 03236484701 09203194901 02203122501 02203122502 02203122503 02203122504 02203122601 02203122602 02203122603 02203122604 11226426701 03203142501 03203142502 05203157501 05203157502 05203157503 05203157601 05203157602 05203157603 05203157604 05203157504 10193084101 09226392902 05193018501 08203193401 08203193402 08203193403 07216151601 07216151601 02256888101 01256839901 06236541501 10152425602 06216119401 12182945101 09182915101 08246758501 11182940902 11193101101 10246773801 01203111201 01216046301 02203130401 03192992401 12182948001 05193021901 11216226301 02203136301 01246652801 01203122501 01203122502 01203122503 01203122504 01203122601 01203122602 01203122603 01203122604 10193084001 09182915901 09182915902 09193066701 05236514701 03226301001 12236630301 12236630303 04226315101 10193084002 10182927201 10193082701 12182946801 08193059801 02226274001 01192967301 11193099201 07203179601 01203114201 11246792901 11246790701 11246790703 02226274201 02226274202 02226274203 08236568601 03226289804 06193009601 06193009602 01192956301 09193071501 0919371501 08203190801 08182901101 08182901102 08182901103 04216090901 02236473201 12246806301 06216121801 06216121802 06216121803 06216121804 06216121805 06216121806 10216191301 10182930001 02203137801 07236553801 12216232501 12216232503 01256840201 03236489601 03236489603 05193018701 03192986401 06226336201 11193098201 07216145901 10203210901 05193020101 05193020201 01192967401 01236449801 09193068001 08216157101 05203162001 06203164901 12236631201 09203199501 08203193601 06193031201 01192958901 11182936701 08182900501 08182900502 09193723010 09193723020 06193037201 06226338401 06226338402 05236516301 01246647401 02203131901 10193083101 09226388401 01216015501 04246699001 04246699002 04246699003 06203170401 12182947801 04193006501 08203185601 11216214101 10182930901 12236633401 12236633402 09193068601 12236633601 09182913801 09182913802 02246673601 05182851401 10226412301 05246713201 09182915201 03226287701 12193109801 06236537701 06236537702 06236537703 06236537704 08236571901 08236563101 07216152701 01236452801 05203156601 10203212601 10203212602 10203212603 10203212604 02256869801 03256916201 03256923701 03256923702
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 Commerce206 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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