Z-1311-2026Class II

Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number...

Name: Z-1311-2026 Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number...
Creator: Etac a/s
Published: 2025-11-17
License: https://open.fda.gov/license/

Etac A/S / initiated 2025-11-17 / Open, Classified / root cause: design

FDA source

ETAC A/S began a recall of Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The... on 2025-11-17. FDA classified it as Class II and gives the reason as "A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1311-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-17
Posted: 2026-02-05
Recalling firm: Etac A/S
Product: Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Root cause tag: design
FDA root cause: Component design/selection
Action: On November 17, 2025 customers were notified vis a phone call. Notifying them that they will receive an email with the Field Safety Notice and Response Form. The customers were emailed Field Safety Notice letters on or around November 20, 2025. Corrective action: To reduce the risk of further incidents, replacement units are offered for all potentially affected products. Continued use is safe as long as the lifting bar can move freely and remains vertical during the lifting cycle with or without load. If this is not the case, or if there is any doubt about the product s functionality, the unit must be taken out of service immediately. The components in the defective units (Mover 205 and Mover 300) will gradually be replaced in the coming months. The affected lifting bars will likewise be replaced.
Quantity in commerce: 25 units
Distribution: Worldwide - US Nationwide distribution in the state of PA and the countries of Australia, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Poland, Qatar Spain, Sweden, Switzerland, UK.
Product codes and lots: (1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1311-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1308-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1309-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1310-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1311-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05

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)