Getinge 9100-Series Washer Disinfector models: 9120E — Class II medical device recall Z-1078-2022
Ongoing recall by Getinge Usa Sales Inc, reported 2022-05-25, distributed in AZ, CA, CO, CT, DC, FL, GA, ID…. Inadequate documentation verifying whether device installation has been executed in accordance with the manufa
| Recall number | Z-1078-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2022-04-01 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Distributed | 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 |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, HK, IT, JP, KR, KW, MX, NL, NO, NZ, OM, PK, PL, PT, QA, RS, SA, SE, SG, TH, TR, TW, VN |
| Quantity | 127 |
| UPC / GTIN / UDI-DI | 07340153710023, 07340153710030, 07340153710047, 07340153710054, 07340153710061, 07340153710078 |
| Serial numbers | WAA076270, WAA085559, WAA086373, WAA086376, WAA086914, WAA086915, WAA087395, WAA087675, WAA087676, WAA087754, WAA088007, WAA088008, WAA088273, WAA088274, WAA088276, WAA088464, WAA088465, WAA088563, WAA088677, WAA088678, WAA088684, WAA088685, WAA088798, WAA088830, WAA088871 and 102 more |
| Model numbers | 9120E, 9122EW, 9125E, 9127E, 9128E, 9128EW |
Product
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1078-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.