FDA Medical Device Recalls (openFDA)
LUMENIS, LTD.: OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
- Recall number
- Z-2344-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2025-07-22
- Posted
- 2025-08-21
- Terminated
- not on file
- Reason
- The potential for unsterilized product within finished product labeled as sterile.
- 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 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
- 13 units
- Distribution
- Domestic: PA, WI; International: Germany, India;
- Lot, serial or model codes
- UPN: AC-2003748; UDI-DI: 07290109142807; Batch Numbers: 32644549 and 32769567; Expiration Date: 22Aug2025;
- 510(k) numbers
- ["K130164"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3004135191
- Firm city
- Ilit
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28