Getinge brand --- large capacity — Class II medical device recall Z-2079-2012
Terminated recall by Getinge USA Inc, reported 2012-08-01, distributed in IN, KS, MD, NM, TX. Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series
| Recall number | Z-2079-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge USA Inc, Rochester, NY, United States |
| Recall initiated | 2012-05-25 |
| Classified | 2012-07-26 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2016-05-18 |
| Distributed | IN, KS, MD, NM, TX |
| Countries outside the US | CA, MX |
| Quantity | 8 washers |
| Serial numbers | W50017381, W50020296, W50020952, W50024258, W50024259, W50025790, W50026573, W50028138 |
Product
Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and 9128
Reason for recall
Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error.
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-2079-2012. 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.