Getinge Usa Sales Inc 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Getinge Usa Sales Inc
Lot Codes / Batch Numbers
UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312
Products Sold
UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312
Getinge Usa Sales Inc is recalling Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector due to Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shoc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Getinge issued to U.S. consignees Medical Device Correction Letter dated April 13, 2022 via FedEx delivery. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any Getinge CM320-series Washer Disinfectors with the REF number/serial numbers listed on page 1. You can continue to use Getinge CM320-series Washer Disinfectors until the corrective action is performed; there are no precautionary actions necessary. 2. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. A Getinge service technician will review the Installation Checklist and verify that each of the steps were performed to ensure continual safe operation of your cart washer(s). This review and verification will be performed. Questions contact your Getinge representative or Technical Support please call (888) 943-8872 (options 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Technical Support can also be reached via email at techsupportIC.us@getinge.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026