Summary
The FDA issued a Class III for Penner Pacific Bathing Spa, Model Numbers 360020-1P by Penner Patient Care, Inc.. Reason: The device does not bear a unique device identifier..
Details
Source
Device Recall
External ID
Z-1502-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Lot/Code Info: 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
Quantity Affected: 45 units
Reason for Recall
The device does not bear a unique device identifier.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-13
Company
Aurora, NE
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Penner Patient Care, Inc. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Penner Patient Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Penner Patient Care, Inc. have FDA actions?
Penner Patient Care, Inc. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1502-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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