FDA recall Z-2344-2025

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2025-07-22

Report date

2025-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Yokne'Am Ilit, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2344-2025