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
- Patient Bathing Spa System
- Model numbers
- 860010-1L, UDI-DI: 0085007365409
- 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 used in some healthcare settings to bathe patients who cannot be easily moved. It may be employed in daily hygiene routines.
Why This Is Dangerous
A missing unique device identifier prevents traceability and regulatory tracking of the device in medical records and adverse-event systems.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Facilities may need to identify affected units in inventory and coordinate with the manufacturer for recall steps. No injuries have been reported to date.
Practical Guidance
How to identify if yours is affected
- Verify model number 860010-1L on the device label.
- Check for UDI label with DI 0085007365409.
- Compare serial numbers against the list provided in the recall documentation.
Where to find product info
Refer to the FDA recall page and the Penner Patient Care notice for instructions.
What timeline to expect
Remedies or replacements, if offered, typically take weeks to process; specifics not provided in the notice.
If the manufacturer is unresponsive
- Escalate to FDA CDRH if the manufacturer is slow to respond.
- File a consumer complaint with CPSC if safety issues arise.
How to prevent similar issues
- Always confirm devices have a UDI label before purchase.
- Verify recalls via the FDA recall database.
- Request written recall procedures from healthcare suppliers.
Documentation advice
Keep the recall notice, product labels, serial numbers, and all correspondence with the manufacturer for your records.
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Product Details
Model numbers: 860010-1L. Sold nationwide in the United States. Sold from unknown date. Price unknown.
Reported Incidents
No injuries or incidents have been reported.
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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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