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 Device
- Model numbers
- 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-XCT, 360030-XCTS +3 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
The Penner Pacific Bathing Spa is a bathing device intended for patients or caregivers in medical or home settings. It is part of a line of health and personal care devices.
Why This Is Dangerous
A missing unique device identifier prevents tracking of the device for recalls, adverse event reporting, and post-market surveillance.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers face immediate discontinuation requirements and potential refunds, with no reported injuries yet. The noncompliant device could hinder safety investigations.
Practical Guidance
How to identify if yours is affected
- Compare your device model number to the list in the recall.
- Check if your device has a UDI or unique device identifier present on the label.
- Inspect serial numbers listed in the recall to determine exposure.
Where to find product info
UDI and serial numbers appear on the device packaging and documentation provided by Penner Patient Care.
What timeline to expect
Refunds or replacements will follow the manufacturer’s process, with details provided in the recall notice.
If the manufacturer is unresponsive
- File a complaint with the FDA or consumer protection agencies if the company does not respond within stated timelines.
- Keep a record of all communications and dates.
How to prevent similar issues
- Verify UDI during future purchases of medical devices.
- Request documentation showing regulatory identifiers and safety records.
- Only purchase from reputable distributors with clear recall policies.
Documentation advice
Keep photos of the device, packaging, serial numbers, dates of purchase, and all correspondence with the manufacturer.
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Product Details
Brand: Penner Patient Care. Product: Penner Pacific Bathing Spa. Model Numbers: 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT. Quantity: 206 units. Distribution: US Nationwide. Recall Date: 2025-08-13. FDA enforcement listing: Z-1503-2026.
Reported Incidents
No injuries or incidents have been reported in the recall notice.
Key Facts
- 206 units recalled in the United States
- No unique device identifier present
- Recall status: ACTIVE
- Hazard level: HIGH
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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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