HIGH

Penner Patient Care Penner Pacific Bathing Spa Recalled for Missing UDI (25 Units, 2025)

Penner Patient Care recalled 25 Penner Pacific Bathing Spas nationwide after confirming the device does not bear a unique device identifier. The missing UDI impedes traceability and oversight. Stop using the device and follow the manufacturer’s recall instructions.

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

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

Penner Pacific Bathing Spa is a medical device intended for bathing in a care setting. It is distributed nationwide in the United States.

Why This Is Dangerous

The device lacks a unique device identifier, which impedes traceability and postmarket safety monitoring.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

No injuries reported to date. The missing UDI could complicate recalls and adverse event reporting for healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Check model numbers on your device: 390010-1, 390010-X, 390010-2
  2. Check for UDI: 0085007365406
  3. Review serial numbers list for matches in the provided recall data
  4. Compare with the recall notice on FDA’s enforcement page

Where to find product info

UDI-DI: 0085007365406; Serial Numbers listed in recall data; Model numbers 390010-1, 390010-X, 390010-2

What timeline to expect

Refunds or replacements not specified; typical recall timelines range from 4-8 weeks for processing

If the manufacturer is unresponsive

  • File a consumer complaint with the FDA if the company is unresponsive
  • Document all correspondence and keep evidence of the recall notice

How to prevent similar issues

  • Verify UDI presence on any medical device before purchase
  • Check for recall notices from FDA and manufacturer
  • Prefer products with clear, accessible UDI labeling and documentation

Documentation advice

Keep the recall notice, serial numbers list, model numbers, and any correspondence with the manufacturer for records

Product Details

Model numbers: 390010-1, 390010-X, 390010-2. Brand: Penner Patient Care. Sold nationwide in the United States. Quantity: 25 units. Recall date: 2025-08-13.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Quantity: 25 units
  • Model numbers: 390010-1, 390010-X, 390010-2
  • UDI-DI: 0085007365406
  • Serial numbers: 11185169701, 01205459101, 09236589001, 08226376601, 05236519007, 07154096101, 091851
  • 23501, 09205645001, 06216123501, 06216123502, 06216123503, 04246695301, 05205559701, 05226325001, 05
  • 226333501, 03216074602, 03216074603, 03216074604, 04195277301, 04216084201, 05246707001, 06195314201

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
390010-1
390010-X
390010-2
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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