FDA Medical Device Recalls (openFDA)
Pentax of America Inc: 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.
- Recall number
- Z-1075-2017
- Recalling firm
- Pentax of America Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-12-12
- Posted
- not on file
- Terminated
- 2019-03-22
- Reason
- Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.
- Root cause
- Labeling design
- Action
- The firm, Pentax Medical, sent an "U.S. URGENT FIELD CORRECTION" letter and a Return Response form dated December 12, 2016 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all users read and carefully follow the revised IFU in order to properly operate and reprocess the affected product; contact your PENTAX Medical sales representative to arrange for training regarding the new procedures, and complete and return the FIELD CORRECTION RESPONSE FORM via fax to: PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or email a pdf copy to customeradvisories@pentaxmedical.com even if you no longer possess the product. If you have any questions regarding this action, please feel free to contact us at: 800-431-5880 (8:30 AM-5:00 PM, Monday-Friday, EST) or email: customeradvisories@pentaxmedical.com.
- Quantity
- 2,056 (1,545 (US) and 511 (OUS))
- Distribution
- 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.
- Lot, serial or model codes
- Model #'s 9106 and 9108
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EQL
- Firm FEI
- 1000080301
- Firm city
- Montvale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28