Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Summary
The FDA issued a Class III for Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 by Penner Patient Care, Inc.. Reason: The device does not bear a unique device identifier..
Details
Source
Device Recall
External ID
Z-1507-2026
Action Date
2026-03-18
Status
Ongoing
Category
device
Product Description
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Lot/Code Info: UDI-DI: 0085007365408; Serial Numbers: 08216172001 07205587101 09195387501 06216130401 06226336703 03226285001 07205587102 07205587102 10216194401 05205566901 08205620801 08246753903 06226345801 05216107103 08216170401 08195374901 09205629101 02226268801 05216098901 05246710101 04226317301 01226251403 08195367701 02226274601 08195367501 11226430901 10246773202 10246778301 02205500703 12195458301 03226297101 10205654401 10205654402 10246773201 01236457201 10195408001 05216106401 11216217002 06226336702 02256885901 10246776501 01205470801 02205500701 02216027601 09195396901 02236474901 02216042601 06246726801 01205470701 01236457202 02226268802 04216087001 03236497001 02246658801 07205601501 09216184102 10205654302 11216217001 04205552801 08195374801 03205534001 05205553001 05205553002 07205605501 07205605502 07205605503 07205605504 07205605505 02226278501 03236482501 01246639801 01246651201 01246651202 11236614902 08195367801 01226251401 09205628801 06216115102 09216184103 08246752402 11226432201 02256890001 09246763202 09246767901 09246767902 08216167602 04246689601 11246799301 11205673701 12226438801 06216132401 06216132402 07216147101 09216184101 11216212801 09205638801 09236593102 01246654601 01256819701 01256858401 11246799302 07226367202 02246663102 04205552701 01205488401 04246702501 12246803401 04226309009 06246728901 06216130301 09205633201 04216094201 12226445201 08216167601 11205674401 06226337201 09246763201 10205659001 09226400901 09236593101 10205658101 09226387902 02205504901 04205552902 05216101101 05226330401 04246702501 01256858402 03256936501 10205653401 10205654301 01236461401 12236627901 04236504902 12226441901 05226330402 05216107101 10205653402 01216010402 05236517801 02236464701 03246677401 04236504901 07236550501 12195443001 02236478301 11226426301 01205479701 03205534101 01226251402 08236577101 09226387901 07246737901 10246787801 06205578701 06205578702 01226262601 08203185603 08236579201 02205500702 10226420401 08246752401 11216222502 08195368801 10216194402 08236572401 03236492701 07216150101 09226390101 03205517901 03226285002 07216150102 06216130302 10246789501 09226387903 09216176801 08246753901 06216115101 04205552901 11216210801 08195374902 04205552702 08226367703 02205504501 12216230701 08236579202 08216167603 03256906001 04256955501 03256908201
Quantity Affected: 190 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-1507-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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