Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes Recalled by Pentax of America Inc Due to Pentax is initiating a Field Correction to revise...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pentax of America Inc directly.
Affected Products
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.
Quantity: 2,056 (1,545 (US) and 511 (OUS))
Why Was This Recalled?
Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Pentax of America Inc
Pentax of America Inc has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report