Getinge CM320 Series Washer Disinfector — Class II medical device recall Z-1124-2021
Terminated recall by Getinge Group Logistics America, LLC, reported 2021-02-24, distributed nationwide. The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/
| Recall number | Z-1124-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Group Logistics America, LLC, Wayne, NJ, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-02-16 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2022-07-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CN, CZ, DE, DK, FI, FR, HK, IT, JP, KR, KW, NO, SE, SI, SK |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 07340153700178, 07340153700185, 07340153700192, 07340153700208, 07340153700215, 07340153710153 |
| Serial numbers | 31253, 31260, 31286, 31299, W50026718, W50027250, W50029991, W50034570, W50039234, WAA062340, WAA062341, WAA070170, WAA070618, WAA070619, WAA081312, WAA085063, WAA089556, WAA093936, WAA094247 |
| Model numbers | CM320 |
Product
Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure.
Reason for recall
The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.
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-1124-2021. 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.