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

Recall Z-2052-2018 — Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

U.S. FDA — Device Enforcement · United States · 2018-05-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2052-2018
Date of alert: 2018-05-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Hobbs Medical, Inc.
Product category: device
Product type: Devices

Reported risk: Device was marketed for uses outside the 510(k) clearance.

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.

Recall Z-2052-2018 — Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

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