FDA Medical Device Recalls (openFDA)
Lumenis, Inc.: Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
- Recall number
- Z-2652-2010
- Recalling firm
- Lumenis, Inc.
- Product
- Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
- Status
- Terminated
- Initiated
- 2010-07-27
- Posted
- 2010-09-30
- Terminated
- 2010-10-05
- Reason
- Firm did not have proper 510(K) clearance.
- Root cause
- Component change control
- Action
- Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.
- Quantity
- 250 probes (25 boxes, each containing 10 probes)
- Distribution
- FL, IL, MD, CO and TX
- Lot, serial or model codes
- Model numbers: GA-0040061;, GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-0040066 Lot numbers: 942439; 946478; 947498; 942440; 947496; 010120; and 947501
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HQF
- Firm FEI
- 1720381
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
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