Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2448-2021 — 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 Channel

U.S. FDA — Device Enforcement · United States · 2021-07-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2448-2021
Date of alert: 2021-07-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Pentax of America Inc
Product category: device
Product type: Devices

Reported risk: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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