Z-2652-2010

Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO

Name: Z-2652-2010 Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
Creator: Lumenis, Inc.
Published: 2010-07-27
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2010-07-27 / Terminated

FDA source

Lumenis, Inc. began a recall of Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO on 2010-07-27. The reason FDA records is "Firm did not have proper 510(K) clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2652-2010
Status: Terminated
Initiated: 2010-07-27
Posted: 2010-09-30
Terminated: 2010-10-05
Recalling firm: Lumenis Ltd
Product: Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
Product code: HQF Laser, Ophthalmic
Reason for recall: Firm did not have proper 510(K) clearance.
FDA 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 in commerce: 250 probes (25 boxes, each containing 10 probes)
Distribution: FL, IL, MD, CO and TX
Product codes and lots: 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

Product code HQF

The FDA recall record names no cleared device, and no clearance has been matched to it.

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)