Z-0453-2013Class II

OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for...

Name: Z-0453-2013 OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for...
Creator: OmniGuide, Inc.
Published: 2012-11-05
License: https://open.fda.gov/license/

Omni-Guide Holdings, Inc. / initiated 2012-11-05 / Terminated / root cause: manufacturing process

FDA source

OmniGuide, Inc. began a recall of OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and... on 2012-11-05. FDA classified it as Class II and gives the reason as "Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0453-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2012-12-03
Terminated: 2014-10-16
Recalling firm: Omni-Guide Holdings, Inc.
Product: OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Root cause tag: manufacturing process
FDA root cause: Process control
Action: OmniGuide issued letter notifiction on November 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that an OmniGuide sales representative would contact them immediately to recover the affected product. For any questions customers were instructed to call 617-551-8561. For questions regarding this recall call 617-551-8410.
Quantity in commerce: 45 units
Distribution: Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
Product codes and lots: Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1 :

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0453-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-03

Product code GEX

K070157Class IIOmniguide Beam Path CO2 Mark III Waveguide FiberOmniguide, Inc. / cleared 2007-02-01

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)