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, PREGNANT, PETS
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
- Getinge Disinfection Ab
- Product type
- Washer-Disinfector
- Model numbers
- 88-5, Model Number: 88-5. UDI-DI 07340153700109, 07340153700116, Software Version: GD 14080 Rev A
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
This device is a medical washer-disinfector used in healthcare facilities to clean and disinfect instruments.
Why This Is Dangerous
Overheating during operation can lead to device malfunction or safety concerns if calibration is incorrect and the low-pressure alarm fails.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Immediate cessation of use and adherence to recall instructions to protect patients and staff.
Practical Guidance
How to identify if yours is affected
- Check model number 88-5
- Confirm software GD 14080 Rev A
- Note lot numbers if provided: all lots with electrical heating
Where to find product info
Manufacturer recall notice; FDA enforcement page Z-0016-2026; unit labeling on the device
What timeline to expect
Refunds or replacements not specified in the notice; follow manufacturer instructions; expect processing timelines per hospital procurement processes
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital risk management
- Consult regional FDA or equivalent if necessary
How to prevent similar issues
- Ensure calibration procedures are performed per manufacturer protocol
- Verify alarms and sensors are functional during routine checks
Documentation advice
Keep recall notification, serial numbers, calibration records, and communications with Getinge
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Product Details
Model Number: 88-5. UDI-DI 07340153700109 and 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating. Distribution: Worldwide, including US states listed and numerous countries. Recall Date: 2025-08-29. Status: ACTIVE.
Reported Incidents
No specific injuries or incidents are disclosed in the provided recall notice.
Key Facts
- Z-0016-2026 recall reference
- Software GD 14080 Rev A
- All Lot Numbers with electrical heating
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Safety Guide
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