Quick Facts at a Glance
- Recall Date
- August 13, 2025
- Hazard Level
- HIGH
- Brand
- Penner Patient Care
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Model numbers
- UDI-DI: 0085007365403, 360020-1P, 11193097601, 10216195501, 10216195502, 12193104901, 06226342101, 06226342102 +39 more
- Sold at
- Unknown
- 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
Penner Pacific Bathing Spa is a patient bathing device used to assist with in-home or clinical bathing for patients. The recall targets a labeling defect rather than device performance.
Why This Is Dangerous
A missing unique device identifier compromises traceability and postmarket recalls, potentially delaying safety actions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals or homes using the device should halt use and follow recall guidance to avoid untraceable devices.
Practical Guidance
How to identify if yours is affected
- Step 1: Locate device label
- Step 2: Read UDI-DI and serial numbers on the label
- Step 3: Compare with recalled identifiers listed in FDA notice
Where to find product info
Label on the device and any accompanying documentation; recall notice URL provided by FDA
What timeline to expect
4-8 weeks forrefund or replacement processing
If the manufacturer is unresponsive
- Document all attempts to contact Penner Patient Care
- Escalate to consumer protection agencies if no response
- Consider legal counsel for unresolved issues
How to prevent similar issues
- Verify UDI labeling before purchasing medical devices
- Purchase from reputable distributors
- Keep records of product identifiers for future recalls
Documentation advice
Keep recall letter, photos of device labels, serial numbers, dates of purchase, and all correspondence with the company
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial Numbers: long list provided
- US nationwide distribution
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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