Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a… — Class II medical device recall Z-1248-2022
Ongoing recall by Getinge Usa Sales Inc, reported 2022-06-15, distributed nationwide. Verification of installation not documented or may be incomplete, could result in harm to the user such as ski
| Recall number | Z-1248-2022 |
|---|---|
| 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 | 2022-04-13 |
| Classified | 2022-06-08 |
| Reported by FDA | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| UPC / GTIN / UDI-DI | 07340153700185 |
| Serial numbers | W50034570, WAA070170, WAA070618, WAA081312 |
| Model numbers | CM320WU |
Product
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Reason for recall
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
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-1248-2022. 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.