Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc
Summary
The FDA issued a Class I for Hillrom LikoScale component, Product Code 3156232, used with the following adap by Baxter Healthcare Corporation. Reason: 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 r.
Details
Source
Device Recall
External ID
Z-2032-2025
Action Date
2025-07-16
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: All LikoScale Adapter Kits manufactured between 8/27/2013 to 2/27/2025
Quantity Affected: 9839 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-30
Company
Deerfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2032-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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