OmniGuide, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0453-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 5, 2012

Date Posted: December 12, 2012

Recall Number: Z-0453-2013

Event ID: 63642

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

Status: Terminated

Product Quantity: 45 units

Code Information:

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 :

Distribution Pattern:

Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.

Voluntary or Mandated:

Voluntary: Firm initiated