FDA Device Recall Z-2249-2024

Megadyne Medical Products, Inc. · Blue Ash, OH

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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 over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No

Lot / serial / GTIN: Product Code: 0830; UDI-DI: 10614559101797; Lot Number: All distributed lot numbers. Product code has been discontinued from future production.

Quantity: 2584 units

Reason for recall

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.

Recall record

Recall number: Z-2249-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,
Recall initiated: 2024-06-17
Classified by FDA Center: 2024-07-03
FDA published: 2024-07-10
Recalling firm: Megadyne Medical Products, Inc.
Firm location: Blue Ash, OH

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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