OmniGuide BP-ROBOTIC — Class II medical device recall Z-0453-2013
Terminated recall by OmniGuide, Inc., reported 2012-12-12, distributed nationwide. Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into
| Recall number | Z-0453-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OmniGuide, Inc., Cambridge, MA, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2012-12-03 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2014-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 45 units |
| Lot numbers | LA120919BG-P1, LA120920AF-P1, LA120924AG-P1, LA120926AS-P1, LA120926BA-P1, LA121001AQ-P1, LA121001AR-P1, LA121001BZ-P1, LA121001CA-P1, LA121001CB-P1, LA121001CC-P1, LA121002AC-P1, LA121003AL-P1, LA121003AO-P1, LA121003AQ-P1 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0453-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.