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 Device
- Model numbers
- 361910-1A, 361910-XA, 361910-2I, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A +2 more
- 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 device used for patient bathing in healthcare and home settings. It is designed to facilitate sponge baths for patients and individuals needing assistive bathing. This recall concerns regulatory labeling rather than a direct device injury issue.
Why This Is Dangerous
The absence of a unique device identifier hinders regulatory tracking and recall management. It does not specify a direct injury hazard in the recall notice.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The immediate impact is operational for providers and patients who rely on the device. Action is required to avoid regulatory complications and ensure traceability.
Practical Guidance
How to identify if yours is affected
- 1) Compare your device model number to the recall list.
- 2) Look for the absence of a unique device identifier on labeling and documentation.
- 3) Check for the UDI-DI: 0085007365405 in labeling.
- 4) Review serial numbers if provided by the manufacturer.
Where to find product info
Label on the device, user manual, and the FDA recall listing linked in the notice.
What timeline to expect
Recall communications by letter with next steps. Replacement or remedies, if offered, will follow manufacturer instructions.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to FDA MedWatch if there is no response from the manufacturer.
- Consider seeking consumer protection guidance if issues persist.
How to prevent similar issues
- Require UDI labeling on all medical devices.
- Check the FDA UDI database during purchases.
- Ask suppliers for devices with clear UDI labeling and traceability.
- Maintain thorough records of devices and recalls for future reference.
Documentation advice
Keep the recall notice, photograph labels, model numbers, and all correspondence with the manufacturer for records.
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Product Details
Model numbers: 361910-1A, 361910-XA, 361910-2I, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X. UDI-DI: 0085007365405. Serial numbers listed by the manufacturer include thousands of entries in the recall notice. Distribution: US nationwide. Sold by: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 158 units recalled nationwide in the United States
- Hazard: Missing UDI
- Remedy: Stop using; follow manufacturer instructions; contact Penner Patient Care for guidance
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Safety Guide
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