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BioVac

US Endoscopy · Model 00711511 · UDI-DI 00724995203306

KQT Prescription

510(k) clearances

201

Adverse events (1 deaths)

Recalls

Facilities

Description

The disposable BioVac direct suction device is indicated for transendoscopic evacuation, debulking, and/or lysing of blood, retained blood clots, or fluid, such as residual stool, within the gastrointestinal tract through the biopsy/suction channel of flexible gastrointestinal endoscopes. It also provides access for endoscopic device passage and exchange, and allows for supplemental intraprocedural irrigation when desired.

Recalls

Date	Firm	Reason
2026-05-05	Olympus Corporation of the Americas	Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
2026-05-05	Olympus Corporation of the Americas	Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
2026-05-05	Olympus Corporation of the Americas	Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
2026-05-05	Olympus Corporation of the Americas	Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
2025-06-18	Olympus Corporation of the Americas	Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.