FDA Device Recall Z-1997-2023

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

MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery

Lot / serial / GTIN: Model No. 0840; UDI-DI: 10614559103395; All Units.

Quantity: 21,100 units

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Recall record

Recall number: Z-1997-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed US Nationwide.
Recall initiated: 2023-06-01
Classified by FDA Center: 2023-06-29
FDA published: 2023-07-05
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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