Penner Pacific Bathing Spa
Medical device recall Z-1500-2026. 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
- 643 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 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB
643 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 0085007365401; Serial Numbers: 12193105601 09246762101 09246762102 07203174301 07205587001 12236633201 12236633202 09216175802 09216175801 05226320101 05216099201 05216099202 10216200701 01203114101 10193088201 10193088202…
Every code shown here, 1,995 characters
UDI-DI: 0085007365401; Serial Numbers: 12193105601 09246762101 09246762102 07203174301 07205587001 12236633201 12236633202 09216175802 09216175801 05226320101 05216099201 05216099202 10216200701 01203114101 10193088201 10193088202 05205560701 05205559901 07216148001 07216148002 02226267201 02226267202 06246721701 06246721702 05236523001 05236523002 05236523003 03216064601 03216064602 09185135701 09185135702 11246790502 11246790501 04236501905 04236501902 04236501901 04236501904 07226354201 01236448201 01236448202 01236448203 01236448204 01236448205 01236448206 01236448207 01236448208 08142214601 08236570201 05226328502 05226328501 05226328504 05226328505 11195429001 11195429101 09246761301 09246761302 08185103701 01226253101 08195355001 09205628901 09205629001 08246753101 08246753104 08246753105 08246753106 08246753102 08246753103 02236477101 10182928001 10185152601 10236608401 10236608402 09195378101 09195378001 09195378301 09195378201 11195442101 11195442201 06246726708 06246726707 06246726701 06246726702 06246726703 06246726704 10236606001 10236606002 12195444301 10195404401 10205653901 06226349401 06226349402 12246806501 12246806502 05236519001 05236519002 05236519003 05236519004 02226264002 02226264001 05195290601 05195290701 01216023801 06226349201 05193021201 02226266401 12236630001 03246687001 03246687002 03246687003 03246687004 03246687005 03246687006 03246687007 03246687008 03246687009 10246779601 10246779602 11195437901 11195438001 05205560601 10236605801 10236605802 07194096301 07194096401 02246674001 02246674002 05246711101 04246691101 04246692001 04246691102 04246692002 07216151301 07216151302 04193001201 02195237001 07205596501 07205596601 06226351201 06226351202 08236570403 08236570404 08236570401 08236570402 01226260701 01226260702 02246660901 02246660902 02246660903 02246660904 02246660905 02246660906 02246661001 02246661002 02246661003 02246661004 02246661005 02246661006 06236537501 08185108801 08185108802 08185108901 08185108902 06205573101…
FDA’s list runs to 7,754 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 7,754 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.