RecallRadar

FDA Device recall Z-1249-2022

Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgica…

On 2022-06-15 the FDA classified a Class II recall of Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgica… by Getinge Usa Sales, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1249-2022
ClassificationClass II
Statusongoing
Initiated2022-04-13
Published2022-06-15
Last updated2026-09-13 11:56 UTC
CompanyGetinge Usa Sales
DistributionUS

Product

Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD

Reason

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

Identifiers

code_infoUDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.