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 860010-1L
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: 0085007365409; Serial Numbers: 07246737902 10236603401 10226407101 03236488101 03246677601 08226379901 08226385601 12236632601 07226353601 08236572201 04246696501 01256844001 12246811601 06226337201 07236557301 09236582001 02246663101 09246761901 08226369401 08226374601 01246644601 04246691701 08246756001 10236600001 04256958001 04256952001
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-1508-2026
- 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-1508-2026 · Source: openFDA enforcement.