Penner Pacific Bathing Spa
Medical device recall Z-1504-2026. Published in FDA’s Enforcement Report on Mar 18, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 18, 2026. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 158 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The device does not bear a unique device identifier.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X
158 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 0085007365405; Serial Numbers: 07246739501 07216139901 02192979601 11182940903 12193105501 09185135601 09185135602 11246797901 05236523801 08236568901 08236568902 11216211801 10226408001 10226408002 06193032901 04246699301…
Every code shown here, 1,934 characters
UDI-DI: 0085007365405; Serial Numbers: 07246739501 07216139901 02192979601 11182940903 12193105501 09185135601 09185135602 11246797901 05236523801 08236568901 08236568902 11216211801 10226408001 10226408002 06193032901 04246699301 04246699302 06226346001 03192988001 05193026301 08182896501 08182896502 08182896503 08182896504 05216110201 06246732101 06246732102 05193020401 11216226901 09246768801 11203215901 09182915601 04193013701 01203113401 10246774001 09193066801 07226353001 07226359101 01256834801 08236567401 11236611101 11226430001 02246665701 10182930801 03246680001 01192960601 03236486401 06236533901 05236526702 09216179201 10193089801 06236532901 06236532902 06236532903 08182902101 03192995801 03192995802 09193067401 07205595301 04216084401 04193002001 04193002002 11216213101 11182939701 09193074901 09193074902 01236449501 01236449502 03192987401 03203142901 03203142902 02192981501 02192981502 05226324701 03226296101 09203198701 04246693301 07226356501 04216092701 04236503401 11236613601 11236613602 02226270303 04226309007 04226309008 01246648301 01246648302 06081036001 03203140001 03203140002 03205525101 07226356201 03216055401 04193000001 11203216801 11203216802 07193044101 01203116101 01203116102 01203116103 05246713401 05246713402 07246738901 07193050501 10246777701 12226443001 11226427301 05216098101 11226433501 09226401501 08216173101 08216173102 05203162501 06226339001 06226339002 05193018601 04216081201 11182933201 11182933202 11236611301 09236584601 09236584602 07193042101 12182947701 01256823701 10226421501 01256838101 04216081901 10226417301 09193071201 02246672301 07205596301 12236524501 11193098801 03216073501 01256852601 10246788401 02226266601 03192998901 12182946201 10236598101 05193023401 05193023402 01226261601 02203131401 03192987901 03192987902 03192987903 02246671801 04246704401 06203167601 07246745601 07216151101 10195414701 01236457001 06193029401 06193029402 04256970101
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 13, 2025.
- FDA classified it on Mar 9, 2026.
- FDA’s Enforcement Report published it on Mar 18, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Penner Patient Care, Inc., of Aurora, NE.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.