Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Summary
The FDA issued a Class III for Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 56001 by Penner Patient Care, Inc.. Reason: The device does not bear a unique device identifier..
Details
Source
Device Recall
External ID
Z-1506-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Lot/Code Info: UDI-DI: 0085007365407; Serial Numbers: 11154213601 10205645901 10205645902 04226315103 09236585801 09185126701 06195328701 12236630901 03236489605 02226270301 02226270302 02256898401 03164326301 06216124001 11152429201
Quantity Affected: 15 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-1506-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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