--- title: "Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 91... — FDA record Z-1078-2022 | Is It on Recall" description: "Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installati" url: https://isitonrecall.com/recall/fda-device-z-1078-2022-getinge-9100-series-washer-disinfector-models-9120e-9125e-9127e-9128e-9122ew-9128ew/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. — FDA record Z-1078-2022 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Apr 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Getinge Usa Sales Inc - **Quantity**: 127 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1078-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1078-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI Codes: [07340153710023, 07340153710047, 07340153710054, 07340153710061, 9122EW 07340153710030, 07340153710078.] Serial Numbers: WAA088008, WAA088276, WAA089054, WAA089188, WAA089511, WAA091312, WAA092134, WAA097871, WAA098978, WAA087395, WAA087675, WAA087676, WAA088563, WAA088677, WAA088684, WAA088798, WAA088973, WAA090326, WAA090827, WAA090829, WAA091562, WAA092656, WAA092905, WAA093809, WAA094122, WAA094447, WAA095653, WAA095654, WAA095655, WAA096084, WAA096723, WAA096820, WAA099698, WAA100249, WAA100596, WAA100828, WAA102416, WAA102300, WAA102301, WAA086373, WAA088830, WAA089854, WAA089735, WAA089736, WAA090141, WAA090273, WAA090274, WAA091427, WAA093786, WAA094342, WAA095013, WAA095014, WAA096724, WAA098589, WAA099164, WAA098725, WAA100514, WAA100695, WAA100704, WAA100832, WAA101375, WAA100834, WAA101893, WAA076270, WAA085559, WAA086376, WAA086914, WAA086915, WAA088007, WAA088273, WAA088464, WAA088465, WAA087754, WAA088678, WAA088685, WAA088871, WAA088998, WAA089258, WAA089356, WAA089446, WAA089970, WAA089969, WAA090495, WAA090615, WAA090746, WAA091561, WAA091184, WAA091560, WAA091563, WAA091564, WAA091869, WAA091870, WAA091873, WAA091868, WAA092136, WAA091872, WAA092904, WAA093646, WAA093882, WAA093967, WAA094123, WAA094202, WAA094284, WAA094285, WAA094286, WAA094617, WAA094601, WAA095421, WAA096425, WAA096427, WAA096428, WAA097298, WAA098056, WAA099694, WAA099450, WAA099451, WAA099695, WAA099697, WAA100127, WAA100826, WAA100827, WAA100830, WAA101342, WAA101894, WAA103173, WAA088274, WAA093968 | Match all identifying details in the current notice. A brand name alone is not enough. ## 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, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [District of Columbia](https://isitonrecall.com/state/district-of-columbia/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Texas](https://isitonrecall.com/state/texas/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Washington](https://isitonrecall.com/state/washington/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) ## Dates in the source - **Report date**: May 25, 2022 - **Recall initiation date**: Apr 1, 2022 - **Center classification date**: May 13, 2022 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1078-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Getinge Usa Sales Inc records](https://isitonrecall.com/brand/getinge-usa-sales-inc/)