Unrated Medical device recall · FDA · Published April 1, 2022

Getinge 9100-Series Washer Disinfector Recall: Installation Documentation Hazard

Getinge recalls specific washer disinfectors due to inadequate installation documentation risks. Affected models include 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. Check serial numbers or UDI codes for recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1078-2022Medical device Getinge ›

Recall notice

Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.

Take action

Contact the company

Recalling firmGetinge Usa Sales Inc1 Geoffrey Way · Wayne, NJ 07470-2035

✎ GovInfoNow plain-language explainer

Getinge is recalling certain washer disinfectors because installation documentation may be missing, which could cause installation failures and hazardous situations. This affects healthcare facilities using these devices for cleaning and disinfection. Read more at govinfonow.com/recall/60850-getinge-9100-series-washer-disinfector-recall-installation-documentation-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/60850-getinge-9100-series-washer-disinfector-recall-installation-documentation-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1078-2022

Cite this page

“Getinge 9100-Series Washer Disinfector Recall: Installation Documentation Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60850-getinge-9100-series-washer-disinfector-recall-installation-documentation-hazard. Based on FDA recall #Z-1078-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1078-2022%22&limit=1).

Getinge Usa Sales Inc recalled Getinge 9100-Series Washer Disinfector models due to inadequate documentation verifying installation compliance, which can lead to hazardous situations, according to the FDA on April 1, 2022.

How to tell if you have it

Brand: Getinge
Product: Getinge 9100-Series Washer Disinfector
Models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW
UDI Codes: 07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078
Units affected: 127

The hazard

The recall cites inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This deficiency can lead to installation failure modes and hazardous situations.

Context

GovInfoNow's records show Getinge Usa Sales Inc has 16 other recalls on record since December 9, 2021. Recent brand recalls include a January 15, 2025 vaporizer recall for hydrogen fluoride risk and an October 3, 2024 mobile operating table recall for error code 50037. Other recent recalls of similar products include a November 19, 2025 Steris AMSCO 7052HP Washer/Disinfector recall for electrical arcing risk.

How to tell if you have this one

Check if your device has a serial number starting with WAA followed by 8 digits, or a UDI code from the list provided in the recall notice. The affected models include 9120E, 9125E, 9127E, 9128E, 9122EW, and 9128EW.

Brand
Getinge
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Installation Documentation
Verify that your device has proper installation documentation as required by the manufacturer.

Where it went and when

Where it was distributed

Distributed in 32 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Texas, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 54 days after the firm started it.

Apr 1, 2022Firm started the recall
May 13, 2022FDA classified it Class II
May 25, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60850-getinge-9100-series-washer-disinfector-recall-installation-documentation-hazard">Getinge 9100-Series Washer Disinfector Recall: Installation Documentation Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1078-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1078-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.