Data Foundry

Medical device recalls 2022

Product Name: GCX Channel Mounting Accessory Model/Catalog Number:… — Class II medical device recall Z-1309-2022

Ongoing recall by Skytron, Div. The KMW Group, Inc, reported 2022-07-06, distributed nationwide. Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon

Recall numberZ-1309-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSkytron, Div. The KMW Group, Inc, Grand Rapids, MI, United States
Recall initiated2022-06-02
Classified2022-06-30
Reported by FDA2022-07-06
DistributedNationwide (US)
Countries outside the USCA, JP
Quantity731
UPC / GTIN / UDI-DI10841736100889
Model numbersH8-300-40-A

Product

Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A

Reason for recall

Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.

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-1309-2022. 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.