Colonoscope Family # 1-Pentax Video Colonoscopes — Class II medical device recall Z-2448-2021
Ongoing recall by Pentax of America Inc, reported 2021-09-22, distributed nationwide. Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video
| Recall number | Z-2448-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pentax of America Inc, Montvale, NJ, United States |
| Recall initiated | 2021-07-14 |
| Classified | 2021-09-10 |
| Reported by FDA | 2021-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 28,849 units |
| Model numbers | EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK, EC-3890TLK, EC34-I10L, EC38-I10L, EC3890LZI |
Product
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
Reason for recall
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
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-2448-2021. 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.