Penner Pacific Bathing Spa
Medical device recall Z-1503-2026. 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
- 206 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 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
206 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 0085007365404; Serial Numbers: 02216037601 03246681301 11193096501 07216136901 07216138701 02256869801 03246682501 11182940901 11193101101 03226290001 03226290002 01162459901 01203113001 01203113002 01203113003 07203175801…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 2,509 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 2,509 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
-
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.