FDA Device recall Z-1267-2020
Pentax Video Colonoscope Model: EC34-i10L
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Pentax Video Colonoscope Model: EC34-i10L by Pentax, citing distributed in the USA without an approved 510K.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1267-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-03 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pentax |
| Distribution | MA, NC |
Product
Pentax Video Colonoscope Model: EC34-i10L
Reason
Distributed in the USA without an approved 510K
Identifiers
| code_info | Serial Numbers: L110300, L110301, L110303, L110306 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1267-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.