HIGH

Getinge Recalls 88-Series Washer-Disinfector Due to Overheating Risk

Getinge recalled 788 units of its 88-Series Washer-Disinfector on August 29, 2025. The device may overheat if the circulation pressure calibration is incorrect and the low-pressure alarm fails. This recall affects devices distributed worldwide, including several U.S. states.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
Getinge Disinfection Ab
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Getinge Disinfection Ab or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the Getinge 88-Series Washer-Disinfector, Model Number 88-5. It is identified by UDI-DI Numbers: 07340153700109 and 07340153700116. The devices were sold worldwide, including in the U.S. states of Colorado, Massachusetts, New Mexico, and New Hampshire.

The Hazard

The recalled Washer-Disinfector poses a high risk of overheating during operation. This can occur if the circulation pressure calibration is not performed correctly or if the low-pressure alarm is not triggered.

Reported Incidents

No specific incidents or injuries have been reported at this time. The potential for overheating presents a serious safety risk.

What to Do

Stop using the Washer-Disinfector immediately. Follow the recall instructions provided by the manufacturer. Contact Getinge Disinfection Ab or your healthcare provider for further guidance.

Contact Information

For further assistance, contact Getinge Disinfection Ab. Visit their website or call the customer service line for more information.

Key Facts

  • Recalled model: Getinge 88-Series Washer-Disinfector, Model Number 88-5
  • Quantity: 788 units
  • Hazard: Potential for overheating
  • Stop use immediately and follow recall instructions
  • Contact Getinge Disinfection Ab for guidance

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Classification

Product TypeWasher-Disinfector
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Number: 88-5. UDI-DI Numbers: 07340153700109
07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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