20 Diopter Binocular Indirect Ophthalmoscope — Class III medical device recall Z-0966-2013
Terminated recall by Volk Optical Inc, reported 2013-03-27, distributed in AZ, CA, GA, MN, NJ, NM. The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device eng
| Recall number | Z-0966-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volk Optical Inc, Mentor, OH, United States |
| Recall initiated | 2012-10-25 |
| Classified | 2013-03-18 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2013-06-11 |
| Distributed | AZ, CA, GA, MN, NJ, NM |
| Countries outside the US | JP |
| Quantity | 40 devices |
| Serial numbers | BB09205, BB09213 |
Product
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Reason for recall
The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).
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-0966-2013. 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.