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

Recall Z-2249-2024 — Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing ov

U.S. FDA — Device Enforcement · United States · 2024-06-17 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2249-2024
Date of alert: 2024-06-17
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Megadyne Medical Products, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10614559101797

Reported risk: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

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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