# FDA recall Z-0016-2026

> **Getinge Disinfection Ab** · Class II · device recall initiated 2025-08-29.

## Product

Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

## Reason for recall

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

## Distribution

Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-0016-2026
- **Recalling firm:** Getinge Disinfection Ab
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-29
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Vaxjo, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0016-2026

## Citation

> AI Analytics. FDA recall Z-0016-2026. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-0016-2026. Source: US FDA. Licensed CC0.

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