Pentax Video Colonoscope Model: EC34-i10L — Class II medical device recall Z-1267-2020
Terminated recall by Pentax of America Inc, reported 2020-02-26, distributed in MA, NC. Distributed in the USA without an approved 510K
| Recall number | Z-1267-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2020-01-03 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2021-01-26 |
| Distributed | MA, NC |
| Reason classes | unapproved product |
| Serial numbers | L110300, L110301, L110303, L110306 |
| Model numbers | EC34-I10L |
Product
Pentax Video Colonoscope Model: EC34-i10L
Reason for recall
Distributed in the USA without an approved 510K
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-1267-2020. 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.