Z-2344-2025Class II

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

Name: Z-2344-2025 OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation...
Creator: Lumenis, Ltd.
Published: 2025-07-22
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2025-07-22 / Open, Classified / root cause: manufacturing process

FDA source

LUMENIS, LTD. began a recall of OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft... on 2025-07-22. FDA classified it as Class II and gives the reason as "The potential for unsterilized product within finished product labeled as sterile". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2344-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-22
Posted: 2025-08-21
Recalling firm: Lumenis Ltd
Product: OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The potential for unsterilized product within finished product labeled as sterile.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 13 units
Distribution: Domestic: PA, WI; International: Germany, India;
Product codes and lots: UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2344-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2344-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-21

Product code GEX

K130164Class IIFiberlase Endure CO2 FiberLumenis, Ltd. / cleared 2013-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)