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FDAJanuary 4, 2021device

K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

What to do

FDA enforcement status: Terminated

Brands named

aomori olympusaomori

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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