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OtoLase Starter Kit recallZ-2344-2025 · Lumenis, Ltd. · initiated Jul 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Lumenis, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-2344-2025
Status
Open, Classified
Initiated by the company
Jul 22, 2025
Posted by the FDA
Aug 21, 2025
Recalling firm
Lumenis, Ltd.
Quantity
13 units
Product code
GEX
FDA submissions
K130164
Distribution
Domestic: PA, WI; International: Germany, India;

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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