OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use recallZ-0453-2013 · OmniGuide, Inc. · initiated Nov 5, 2012
Class II Terminated All recalls posted in December 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OmniGuide, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0453-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 5, 2012
- Posted by the FDA
- Dec 3, 2012
- Recalling firm
- OmniGuide, Inc.
- Quantity
- 45 units
- Product code
- GEX
- FDA submissions
- K070157
- Distribution
- Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.
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
Code information (models, lots, serial numbers)
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 :
Other devices under the same FDA submission
1 device cleared under K070157 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Elevate™ ENT Elite Fiber 322001Omniguide, Inc. · Powered Laser Surgical Instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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