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
- Model numbers
- 560010-2L, 560010-XL, 560010-1L
- 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 medical device used to support hydrotherapy or bathing therapies in clinical or home care settings. It is distributed through healthcare channels and intended for patient care.
Why This Is Dangerous
The lack of a unique device identifier can hinder postmarket tracking and safe recall actions, potentially delaying manufacturer communications and corrective actions.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Healthcare providers and patients may need to identify affected devices quickly to avoid using non-identifiable units. The recall may require replacements or proper labeling to ensure traceability.
Practical Guidance
How to identify if yours is affected
- 1) Verify model numbers against 560010-2L, 560010-XL, 560010-1L, 560010-XL.
- 2) Check for the presence of a unique device identifier on the device label.
- 3) Cross-check the UDI-DI 0085007365407 listed in the recall materials.
Where to find product info
Official recall details are on the FDA enforcement page linked in the recall notice. Manufacturer instructions will be provided to healthcare providers.
What timeline to expect
Remedy processing times are not specified. Expect updates through the FDA notice and Penner Patient Care communications.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer or healthcare provider.
- Escalate to FDA recall contacts if there is no response within a reasonable window.
How to prevent similar issues
- Always verify UDI labeling on medical devices before use or patient care.
- Keep recall letters and serial/model information for records.
- Use only devices with proper UDI labeling and packaging.
Documentation advice
Keep the recall letter, model numbers, UDI, serial numbers list, and all correspondence with the manufacturer or provider.
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Product Details
Model numbers: 560010-2L, 560010-XL, 560010-1L. Sold nationwide in the United States. When sold: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- United States nationwide distribution
- Class III medical device recall (per description)
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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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