Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Summary
The FDA issued a Class III for Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 by Penner Patient Care, Inc.. Reason: The device does not bear a unique device identifier..
Details
Source
Device Recall
External ID
Z-1505-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Lot/Code Info: UDI-DI: 0085007365406; Serial Numbers: 11185169701 01205459101 09236589001 08226376601 05236519007 07154096101 09185123501 09205645001 06216123501 06216123502 06216123503 04246695301 05205559701 05226325001 05226333501 03216074601 03216074602 03216074603 03216074604 04195277301 04216084201 05246707001 06195314201 03256918201 03256945401
Quantity Affected: 25 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-1505-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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