The Recall Desk
HighFDA (Devices)·Z-1380-2018·Announced 2018-04-25

Getinge Washer-Disinfector Accessory Recall Due to Unloading Hazard

Getinge is recalling 170 automated loading/unloading systems for Washer-Disinfector 88 Series units. The recall addresses a risk that disinfected goods may fall to the floor if the trolley is not docked.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria for potential physical injury to users.

Plain-English summary

Getinge Disinfection Ab is recalling 170 units of Getinge AGS, FSLC, FSUC, and RC accessories intended for use with the Washer-Disinfector 88 Series. These automated loading and unloading systems function as conveyors for unloading wash carts from the washer-disinfectors. The affected units are identified by UDI codes 07340153700109 and 07340153700116, along with specific serial numbers listed in the recall documentation.

The recall is being issued because there is a potential for a cart containing disinfected goods to unload without the trolley being properly docked. If this occurs, the disinfected goods could fall to the floor. This presents a risk of injury to nearby users and potential damage to the goods and equipment.

The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Australia, Belgium, Brazil, Canada, China, and others. Users of these systems should check their equipment against the provided serial numbers and UDI codes to determine if they are affected.

The recalled product

Product
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/
Affected units
170

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI Info: 07340153700109

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Getinge Disinfection Ab under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →