Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0453-2013 — 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,

U.S. FDA — Device Enforcement · United States · 2012-11-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0453-2013
Date of alert: 2012-11-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: OmniGuide, Inc.
Product category: device
Product type: Devices

Reported risk: Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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