Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Summary
The FDA issued a Class III for Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X by Penner Patient Care, Inc.. Reason: The device does not bear a unique device identifier..
Details
Source
Device Recall
External ID
Z-1499-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
Lot/Code Info: UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401
Quantity Affected: 21 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-1499-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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