Class III — the FDA judged the product is unlikely to cause harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Why it was recalled
The device does not bear a unique device identifier.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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 08195368801 10216194402 08236572401 03236492701 07216150101 09226390101 03205517901 03226285002 07216150102 06216130302 10246789501 09226387903 09216176801 08246753901 06216115101 04205552901 11216210801 08195374902 04205552702 08226367703 02205504501 12216230701 08236579202 08216167603 03256906001 04256955501 03256908201
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution.
Recall record
- Recalling firm
- Penner Patient Care, Inc.
- Product type
- Devices
- Recall number
- Z-1507-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Aurora, NE
- Recall initiated
- 2025-08-13
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1507-2026 · Source: openFDA enforcement.