FDA Medical Device Recalls (openFDA)
Seiler Instr. & Mfg. Co. Inc.: Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
- Recall number
- Z-1294-2018
- Recalling firm
- Seiler Instr. & Mfg. Co. Inc.
- Product
- Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
- Status
- Open, Classified
- Initiated
- 2017-01-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post.
- Root cause
- Use error
- Action
- The customer was notified via email on about January 4, 2017. Instructions included that the scope only tips if the user has it extended all the way out and is pulling on the handles of the scope. The end user must not pull on the handles of the scope when it is extended. They were also instructed to educate personnel on this matter. For further questions, please call (314) 968-2282.
- Quantity
- 43 units, but 1 affected
- Distribution
- Worldwide Distribution - US Distribution to the states of : CA, CO, FL, IL, MN, NV, OK, TX., and to the countries of : Canada, China, Ecuador, England, Greece, Guatemala, Jordan, Lebanon, Mexico, Romania, Russia, South Korea, Taiwan, Japan and United Arab Emirates.
- Lot, serial or model codes
- Model Number 6 ENT
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EPT
- Firm FEI
- 1927430
- Firm city
- Saint Louis
- Firm state
- MO
- 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