Pentax of America Inc: Medical Device Recall in 2017 - (Recall #: Z-1075-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 12, 2016

Date Posted: February 1, 2017

Recall Number: Z-1075-2017

Event ID: 76089

Reason for Recall:

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

Status: Terminated

Product Quantity: 2,056 (1,545 (US) and 511 (OUS))

Code Information:

Model #'s 9106 and 9108

Distribution Pattern:

Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated