Z-0640-2022Class II

Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015

Name: Z-0640-2022 Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Creator: Hill-Rom, Inc.
Published: 2021-12-23
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2021-12-23 / Open, Classified / root cause: manufacturing process

FDA source

Hill-Rom, Inc. began a recall of Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015 on 2021-12-23. FDA classified it as Class II and gives the reason as "Missing bushing on Liko M220 and M230 causing wear and potential for patient falling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0640-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-23
Posted: 2022-02-16
Recalling firm: Hill-Rom Inc.
Product: Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
Root cause tag: manufacturing process
FDA root cause: Process control
Action: HillRom issued Urgent Medical Device Correction Letter (FSCA Identifier: FA 2021-010-002-LUL-001) via third party on 23 December 2021 via UPS Ground Service to Distributors and Direct Users. Letter states reason for recall, health risk and action to take: 1. Review the product label on your Liko M220/M230 to determine if it is impacted by this field action by identifying the manufacturing date of the device (i.e. Manufacturing date between 2016-DEC-27 and 2021 SEP-01). See figure 2. 2. Please periodically inspect your Liko device for damage or wear. Report visible wearing or damage to your Technical Support Team do not use the device until Technical Support can inspect and repair where necessary. 3. Please fill out the attached response form and return it to Hillrom [email protected] within two weeks Please share this Field Safety Notice with your end users and complete the attached response form and return to [email protected] within two weeks. Contact [email protected] to receive an electronic copy of this notification and response form for onward distribution. Action to be taken by the Hillrom: Upon receipt of the response form, identifying potentially impacted devices, Hillrom or an official Hillrom distributor/representative will be in contact to schedule inspection of your device to confirm presence of the bushing. Where it is confirmed the device is missing the bushing, a replacement slingbar with the bushing will be installed. If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or [email protected]
Quantity in commerce: 1215 units
Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Austria, Bahrain, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Norway, Saudi Arabia, Sweden, Slovenia, Taiwan (Province of China), South Africa, Oman.
Product codes and lots: Serial numbers: 5361393-5362761. Manufactured between 2016-DEC-27 and 2021-SEP-01. UDI: 0887761GMN000034U5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0640-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0639-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-14
Z-0640-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-14

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)