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FDA · Medical devicesClass I

Baxter Healthcare Corporation medical device recall: Hillrom Q-Link 13 component

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
96856
Recall initiated
May 30, 2025
Classified by FDA
Jul 9, 2025
Posted in Enforcement Report
Jul 16, 2025
Recalling firm
Baxter Healthcare Corporation
Firm location
Deerfield, IL, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
2

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

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 the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on May 30, 2025. FDA classified it 40 days later, on Jul 9, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide Baxter Healthcare Corporation has 279 recalls in our records.

Recalled products (2)

  • Z-2031-2025 Class I Ongoing

    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. .

    Codes / lots: 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. .

    Quantity: 9899 units

  • Z-2032-2025 Class I Ongoing

    Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.

    Codes / lots: All LikoScale Adapter Kits manufactured between 8/27/2013 to 2/27/2025

    Quantity: 9839 units

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 96856
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.

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