FDA Medical devices recall ·

Hillrom Q-Link 13 component, Product Code 3156509… recall

This is an FDA Class I recall — the most serious type.

Recall number
Z-2031-2025
Date
(initiated May 30, 2025)
Company / brand
Baxter Healthcare Corporation
1 Baxter Pkwy, Deerfield, IL, United States
Category
Medical devices › Class I
Classification
Class I
Status
Ongoing
Units affected
9899 units
Hazard tags
Fall Injury risk
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .

Why was it recalled?

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

All Q-link 13 manufactured between 8/27/2013 to 2/27/2025: 1) Product Code 2010004, UDI/DI 00887761981775; 2) Product Code 2040044, UDI/DI 00887761981867; 3) Product Code 2040043, UDI/DI 00887761981850; 4) Product Code 2040045A, UDI/DI 00887761943193; 5) Product Code 2040006, UDI/DI N/A; 6) Product Code 2040007, UDI/DI N/A; 7) Product Code 2030001, UDI/DI N/A. .

Distribution

Worldwide

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-2031-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.