HIGH

Penner Pacific Bathing Spa Recalled for Missing Unique Device Identifier (UDI) in 206 Units

Penner Patient Care recalls 206 US units of the Penner Pacific Bathing Spa after the device lacks a unique device identifier. The recall targets models listed with multiple variations and serial numbers. Consumers should stop using the device immediately and follow manufacturer instructions.

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

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

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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

  1. Compare your device model number to the list in the recall.
  2. Check if your device has a UDI or unique device identifier present on the label.
  3. 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.

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
  • Model numbers contain 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-
  • No unique device identifier present
  • Recall status: ACTIVE
  • Hazard level: HIGH

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
360030-1C
360030-1CE
360030-1CTS
360030-XCE
360030-XC
+6 more
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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