FDA Medical Device Recalls (openFDA)
Pentax of America Inc: Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
- Recall number
- Z-2875-2016
- Recalling firm
- Pentax of America Inc
- Product
- Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.
- Status
- Terminated
- Initiated
- 2016-05-31
- Posted
- not on file
- Terminated
- 2017-12-21
- Reason
- Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
- Root cause
- Packaging process control
- Action
- Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex. Customers with questions were instructed to call 800-431-5880, ext. 2064.
- Quantity
- 1719 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
- 510(k) numbers
- ["K131028"]
- PMA numbers
- not on file
- Product code
- EOQ
- 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