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

Recall Z-0098-2018 — STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly

U.S. FDA — Device Enforcement · United States · 2017-10-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0098-2018
Date of alert: 2017-10-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Karl Storz Endoscopy
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 26432020

Reported risk: The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.

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

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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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