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FDADecember 12, 2016device

Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

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

The hazard

Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.

What to do

FDA enforcement status: Terminated

Brands named

pentax

Recall history

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

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