Exact FDA event identifier

Event 97279

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

Open FDA event record

Event summary

Timeline bucket: July 22, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: LUMENIS, LTD.

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

OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.

Z-2344-2025

Recall number: Z-2344-2025
Initiated: July 22, 2025
Classification: Class II
Status: Ongoing
Recalling firm: LUMENIS, LTD.
Quantity: 13 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The potential for unsterilized product within finished product labeled as sterile.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for unsterilized product within finished product labeled as sterile.

Code information

UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;

Distribution pattern

Domestic: PA, WI; International: Germany, India;