Drug & Device Safety Atlas
Class III FDA device recall · Z-1502-2026

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 360020-1P

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: 0085007365403; Serial Numbers: 11193097601 10216195501 10216195502 12193104901 06226342101 06226342102 06226342105 06226342107 03203148701 01226259601 10226410801 06246724701 10203210401 10203210402 05216113101 11193095401 01203118301 05216107301 05216107302 05216107303 05216107304 05216107305 05216108301 05216108302 06193030201 03203147601 09193066601 03216060801 07193052301 09236591501 02246673801 02192976301 03246682701 01192960801 01192960802 06236535501 08152390701 03216065101 05182864901 01142094001 11121856201 03192998301 01192959801 01226256901 03256938801

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-1502-2026
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-1502-2026 · Source: openFDA enforcement.