Recall Z-0597-2024— Megadyne Medical Products, Inc.

Name: FDA recall Z-0597-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-08

Class I · Ongoing

Class I FDA medical device recall by Megadyne Medical Products, Inc., initiated 2023-12-08. It names one FDA 510(k) clearance: K133726. Product: Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode. Reason: 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..

Recalling firm: Megadyne Medical Products, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-12-08
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODEMegadyne Medical Products, Inc.·cleared 2014-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.