Data Foundry

Medical device recalls 2018

Alpha Air 6 ENT Microscope Microscope examination of the human ear — Class II medical device recall Z-1294-2018

Ongoing recall by Seiler Instr. & Mfg. Co. Inc., reported 2018-04-11, distributed in CA, CO, FL, IL, MN, NV, OK, TX. The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the

Recall numberZ-1294-2018
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSeiler Instr. & Mfg. Co. Inc., Saint Louis, MO, United States
Recall initiated2017-01-01
Classified2018-04-02
Reported by FDA2018-04-11
DistributedCA, CO, FL, IL, MN, NV, OK, TX
Countries outside the USAE, CA, CN, EC, GB, GR, GT, JO, JP, KR, LB, MX, RO, RU, TW

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1294-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.