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.

Recall Insight

This FDA Devices action (record #Z-1124-2021) was formally reported on February 24, 2021, with the manufacturer initiating the action on December 21, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Getinge Group Logistics America, LLC is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 189 units total (Domestic 19 units, Foreign 170 units).

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, Norwa…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.