Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- Penner Patient Care
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Penner Patient Care
- Product type
- Bathing Spa System
- Model numbers
- 350010-1, 350000-2, 350010-X
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 13, 2025
Reported by FDA DEVICE
March 18, 2026
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The device does not bear a unique device identifier.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Penner Patient Care, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Penner Pacific Bathing Spa is a patient bathing device used in healthcare or care settings. It is referenced in a nationwide US recall for missing UDI information.
Why This Is Dangerous
The absence of a unique device identifier prevents reliable traceability for recalls and adverse events.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
For consumers and facilities, the missing UDI complicates recall actions and post-market surveillance. No injuries have been reported, but the issue affects traceability.
Practical Guidance
How to identify if yours is affected
- Check if the device has a UDI-DI 0085007365400.
- Compare serial numbers against the recall list provided in the notice.
Where to find product info
UDI on device label; serial numbers and model numbers on the device and recall communications; FDA recall page.
What timeline to expect
Refunds or replacements, if offered, typically processed within 4-8 weeks after eligibility confirmation.
If the manufacturer is unresponsive
- Document all communications with Penner Patient Care, Inc.
- File a report with the FDA recall portal or your local consumer protection agency if the company is unresponsive.
How to prevent similar issues
- Ensure future devices have a clear UDI on the label.
- Shop for medical devices from authorized distributors.
- Verify recall status before purchasing used or refurbished equipment.
Documentation advice
Keep the recall notice, photos of the device, model and serial numbers, and any correspondence with the manufacturer.
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Product Details
Model numbers: 350010-1, 350000-2, 350010-X. Distribution: US nationwide. Recall date: 2025-08-13. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: 350010-1, 350000-2, 350010-X
- UDI-DI: 0085007365400 listed in related data
- No injuries reported
- Active recall as of 2026-03-18
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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