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U.S. Department of Health and Human Services

Class 2 Device Recall OtoLase

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 Class 2 Device Recall OtoLasesee related information
Date Initiated by FirmJuly 22, 2025
Date PostedAugust 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2344-2025
Recall Event ID 97279
510(K)NumberK130164 
Product Classification Powered laser surgical instrument - Product Code GEX
ProductOtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Code Information UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
Recalling Firm/
Manufacturer		 LUMENIS, LTD.
Yokneam Ind. Park
6, Ha-Kidma
Yokne'Am Ilit Israel
For Additional Information ContactRenee Archie
508-683-4000
Manufacturer Reason
for Recall		The potential for unsterilized product within finished product labeled as sterile.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce13 units
DistributionDomestic: PA, WI; International: Germany, India;
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEX
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