Z-1294-2018Class II

Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat

Name: Z-1294-2018 Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat
Creator: Seiler Instr. & Mfg. Co. Inc.
Published: 2017-01-01
License: https://open.fda.gov/license/

Seiler Instrument & Mfg. Co.,Inc. / initiated 2017-01-01 / Open, Classified

FDA source

Seiler Instr. & Mfg. Co. Inc. began a recall of Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat on 2017-01-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1294-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-01-01
Posted: 2018-04-02
Recalling firm: Seiler Instrument & Mfg. Co.,Inc.
Product: Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Product code: EPT Microscope, Surgical
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: Model Number 6 ENT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-04-11	2018-04-02

Product code EPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)