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

FDA device recall Z-2344-2025 · posted 2025-08-21 · Open, Classified

Recall details

Recalling firm

LUMENIS, LTD.

Reason for recall

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

Action taken

On July 22, 2025, URGENT MEDICAL DEVICE REMOVAL - IMMEDIATE ACTION REQUIRED letters were sent to customers. Instructions: " Immediately discontinue use and segregate the affected products to prevent accidental use and follow provided removal instructions on the attachment. " Post this information in a visible location near where the affected products are stored to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any healthcare professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. " If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Any adverse events or quality concerns associated with use of these devices should be reported to Boston Scientific via email at ComplaintCallCenter@bsci.com or FDA s MedWatch Adverse Event Reporting program [www.fda.gov/MedWatch/report.htm or 1.800.FDA.1088 (332.1088)]. We appreciate your understanding as we take action to address this issue. At Boston Scientific, patient safety and customer satisfaction are our priority. We are committed to continuing to offer products that meet the quality standards that you expect from Boston Scientific. Contact your local Boston Scientific representative with any questions.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

GEX

Quantity affected

13 units

Distribution

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

Date initiated

2025-07-22

Date posted

2025-08-21

Location

Ilit, Israel

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