OmniGuide BP-ROBOTIC Fiber Recalled Due to Glue Joint Failure
OmniGuide, Inc. is recalling 45 units of BP-ROBOTIC single-use fibers because a glue joint failure may cause the device to shift and fall into the patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect where a component may separate and fall into the patient, representing a risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
OmniGuide, Inc. is recalling 45 units of the OmniGuide BP-ROBOTIC (BeamPath Robotic) single-use fiber. The product is indicated for the incision, excision, ablation, vaporization, and coagulation of body soft tissues in various medical specialties. The recall is due to a failure of the glue joint, which allowed a portion of the single-use device to shift inside. This defect may cause the device to separate and fall into the patient.
The affected units were distributed nationwide, including in Arizona, Florida, Massachusetts, New York, Ohio, and Oregon. Specific lot numbers are listed in the agency's recall record. The source text does not report any illnesses or injuries associated with this defect.
Healthcare providers and consumers should stop using the affected OmniGuide BP-ROBOTIC fibers immediately. Users should check their inventory for the specific lot numbers identified in the recall and contact OmniGuide, Inc. for instructions on returning the product.
The recalled product
- 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…
- Manufacturer
- OmniGuide, Inc.
- Category
- Medical Device — Surgical Fiber
- Affected units
- 45
Distribution
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