FDA Device Recall Z-0600-2024

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

Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus

Lot / serial / GTIN: UDI-DI 10614559104859 All units within expiry

Reason for recall

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

Recall record

Recall number: Z-0600-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution. US Nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, Eswatini, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Lebanon, Malaysia, Martinique, Morocco, Netherlands, New Caledonia, Norway, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian , Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam
Recall initiated: 2023-12-08
Classified by FDA Center: 2023-12-26
FDA published: 2024-01-03
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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