Exact FDA event identifier

Event 94785

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: June 07, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Rygel Advanced Machines d/b/a Omtech Laser

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

OMTech Desktop Laser Engraver

Z-2129-2024

Recall number: Z-2129-2024
Initiated: June 07, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Rygel Advanced Machines d/b/a Omtech Laser
Quantity: 641

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

Code information

Model: DF0812-40BG, USB-032B-U1

Distribution pattern

US Nationwide