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GENOSS Inflator B40

GENOSS CO., Ltd. · Model GBI-B40S · UDI-DI 08800026512752

PTM
0
510(k) clearances
55
Adverse events (1 deaths)
7
Recalls
56
Facilities

Recalls

DateFirmReason
2025-12-04Merit Medical Systems, Inc.Inflation device handle may detach from the syringe during procedure.
2025-08-05Boston Scientific CorporationThe Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determine
2024-08-19Merit Medical Systems, Inc.Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
2024-08-19Merit Medical Systems, Inc.Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
2024-08-19Merit Medical Systems, Inc.Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
2024-08-19Merit Medical Systems, Inc.Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
2021-06-10Merit Medical Systems, Inc.Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

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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.