GETINGE CM320-SERIES recallZ-1124-2021 · Getinge Group Logistics America, LLC · initiated Dec 21, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge Group Logistics America, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
On 01/12/2021 Getinge initiated a voluntary Medical Device in the U.S for the CM320 Series Washer Disinfector instructing consignees to inspect their device and that a correction kit is currently available and the correction will be completed at no cost to affected customers.
Recall details
- Recall number
- Z-1124-2021
- Status
- Terminated
- Initiated by the company
- Dec 21, 2020
- Recalling firm
- Getinge Group Logistics America, LLC
- Quantity
- 189 units total (Domestic 19 units, Foreign 170 units)
- Product code
- MEC
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of ND, PA, NC, VA, NE, MD, NY, MN and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Norway, Slovakia, Slovenia, South Korea, Sweden, Japan, China, Netherland, Italy, Kuwait and Czech Republic.
Product description
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.
Code information (models, lots, serial numbers)
Product Code/Part Number: CM320 4 WUWD, CM320 3 WWD, CM320K661, CM320K671, CM320K689, CM320K706, CM320K730, CM320WU, CM320WU K981, CM320WUWD. Serial Number: 31253, 31260, 31299, 31286, W50026718, W50027250, W50029991, W50034570, W50039234, WAA070170, WAA081312, WAA062340, WAA062341, WAA070619, WAA085063, WAA089556, WAA093936, WAA094247, WAA070618. UDI Code: 07340153700178 GETINGE CM320WO CM320 2 CHAMBER WO 07340153700185 GETINGE CM320WU CM320 2 CHAMBER WU 07340153700192 GET/NGE CM320WUWO CM320 4 CHAMBER WUWO 07340153700208 GETINGE CM320WWO CM320 3 CHAMBER WWO 07340153700215 GETINGE CM320WWWO CM320 4 CHAMBER WWWO 07340153710153 GETINGE CM320WOK966 CM320 2 CHAMBER WO
Devices named in this recall
6 devices in the FDA device registry whose identifier appears in the recall's code information.
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls3 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices2 recalls1 report
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices1 recall1 report
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices1 recall0 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices1 recall0 reports
- GETINGE CM320-SERIESGetinge Disinfection AB · Disinfector, Medical Devices1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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