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

Recall Z-2257-2023 — MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (S

U.S. FDA — Device Enforcement · United States · 2023-06-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2257-2023
Date of alert: 2023-06-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Megadyne Medical Products, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10614559105146

Reported risk: An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

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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