FDA Medical Device Recalls (openFDA)
Pentax Medical Company: EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
- Recall number
- Z-0819-2012
- Recalling firm
- Pentax Medical Company
- Product
- EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
- Status
- Terminated
- Initiated
- 2011-09-30
- Posted
- 2012-01-20
- Terminated
- 2012-11-27
- Reason
- The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
- Root cause
- Employee error
- Action
- Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
- Quantity
- one unit
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- EE-1580K A110273
- 510(k) numbers
- ["K961564"]
- PMA numbers
- not on file
- Product code
- EOX
- 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
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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