Penner Pacific Bathing Spa
Medical device recall Z-1507-2026. 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
- 190 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 760010-1, 770010-1
190 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 0085007365408; Serial Numbers: 08216172001 07205587101 09195387501 06216130401 06226336703 03226285001 07205587102 07205587102 10216194401 05205566901 08205620801 08246753903 06226345801 05216107103 08216170401 08195374901…
Every code shown here, 1,995 characters
UDI-DI: 0085007365408; Serial Numbers: 08216172001 07205587101 09195387501 06216130401 06226336703 03226285001 07205587102 07205587102 10216194401 05205566901 08205620801 08246753903 06226345801 05216107103 08216170401 08195374901 09205629101 02226268801 05216098901 05246710101 04226317301 01226251403 08195367701 02226274601 08195367501 11226430901 10246773202 10246778301 02205500703 12195458301 03226297101 10205654401 10205654402 10246773201 01236457201 10195408001 05216106401 11216217002 06226336702 02256885901 10246776501 01205470801 02205500701 02216027601 09195396901 02236474901 02216042601 06246726801 01205470701 01236457202 02226268802 04216087001 03236497001 02246658801 07205601501 09216184102 10205654302 11216217001 04205552801 08195374801 03205534001 05205553001 05205553002 07205605501 07205605502 07205605503 07205605504 07205605505 02226278501 03236482501 01246639801 01246651201 01246651202 11236614902 08195367801 01226251401 09205628801 06216115102 09216184103 08246752402 11226432201 02256890001 09246763202 09246767901 09246767902 08216167602 04246689601 11246799301 11205673701 12226438801 06216132401 06216132402 07216147101 09216184101 11216212801 09205638801 09236593102 01246654601 01256819701 01256858401 11246799302 07226367202 02246663102 04205552701 01205488401 04246702501 12246803401 04226309009 06246728901 06216130301 09205633201 04216094201 12226445201 08216167601 11205674401 06226337201 09246763201 10205659001 09226400901 09236593101 10205658101 09226387902 02205504901 04205552902 05216101101 05226330401 04246702501 01256858402 03256936501 10205653401 10205654301 01236461401 12236627901 04236504902 12226441901 05226330402 05216107101 10205653402 01216010402 05236517801 02236464701 03246677401 04236504901 07236550501 12195443001 02236478301 11226426301 01205479701 03205534101 01226251402 08236577101 09226387901 07246737901 10246787801 06205578701 06205578702 01226262601 08203185603 08236579201 02205500702 10226420401 08246752401 11216222502…
FDA’s list runs to 2,318 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 2,318 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.