Class II — Seiler Instr. & Mfg. Co. Inc.
| Recalling firm | Seiler Instrument & Mfg. Co., Inc. |
|---|---|
| Registered facility | Seiler Instrument & Mfg. Co.,Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat. |
| 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. |
| Initiated | 2017-01-01 |
| Classified | 2018-04-02 |
| Recall number | Z-1294-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Seiler Instr. & Mfg. Co. Inc. (Z-1294-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79362/
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