Data Foundry

Medical device recalls 2025

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount — Class II medical device recall Z-1663-2025

Ongoing recall by IHB OPERATIONS B.V., reported 2025-04-30, distributed nationwide. The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engag

Recall numberZ-1663-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmIHB OPERATIONS B.V., Zwolle, N/A, Netherlands
Recall initiated2025-03-27
Classified2025-04-23
Reported by FDA2025-04-30
DistributedNationwide (US)
Quantity112 units
UPC / GTIN / UDI-DI10841736116071

Product

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

Reason for recall

The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1663-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.