Recall Register

Food, drugs, devices › Baxter Healthcare Corporation

Device recall: Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile li

FDA enforcement event 96856 · Class I · initiated 30 May 2025 · status Ongoing

DeviceVoluntary: Firm initiated2 product recordsDeerfield, IL

FDA enforcement event 96856 is a device recall by Baxter Healthcare Corporation of Deerfield, IL, initiated 30 May 2025 and classified Class I, with 2 product records.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Baxter Healthcare Corporation has 193 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Baxter Healthcare Corporation, Deerfield, IL.

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."

Distribution

"Worldwide"

Product records

Recall numberProductQuantityClassStatusReport date
Z-2031-2025Hillrom 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 -…9899 unitsClass IOngoing16 Jul 2025
Z-2032-2025Hillrom 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 3156226.9839 unitsClass IOngoing16 Jul 2025

Context

13%of 2025 device events are Class I945 events that year
2product records in this eventfirm median: 1
193events on this register for the firm

Other enforcement events for Baxter Healthcare Corporation

InitiatedProduct (first record)TypeClassRecords
17 Aug 20260.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare CorporaDrugClass I1
17 Aug 2026Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDrugClass I1
11 Aug 2026Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSDeviceClass II2
6 Aug 2026Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile NonDrugClass II17
24 Jul 2026Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic ContainerDrugClass I1
30 Jun 2026Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration SetsDeviceClass I1
21 May 2026Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung ExpaDeviceClass I4
22 Apr 2026Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: TubingDeviceClass II1
21 Apr 2026Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper BDeviceClass II1
18 Feb 2026Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software DeviceClass II1

All 193 events for Baxter Healthcare Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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 does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.