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

Recall Z-1530-2020 — Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope

U.S. FDA — Device Enforcement · United States · 2019-08-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1530-2020
Date of alert
2019-08-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Karl Storz Endoscopy
Product category
device
Product type
Devices
Reported risk: During a complaint investigation it was determined that an error was observed within the instruction manual included with some scopes. Specifically, The Quick Connector Kits (QCK) and tray information, specified for the STERIS System 1E (SS1E) sterilization method within the instruction manual is incorrect. If the user uses SS1E to sterilize the impacted scopes and referred to the manual concerning the QCK information, the sterility of reprocessed scope cannot be guaranteed.
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.

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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.