Recall Z-1995-2023— Megadyne Medical Products, Inc.

Name: FDA recall Z-1995-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-01

Class I · Ongoing

Class I FDA medical device recall by Megadyne Medical Products, Inc., initiated 2023-06-01. It names one FDA 510(k) clearance: K021077. Product: MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery. Reason: Firm has received reports of patient burns in surgical procedures where device was used..

Recalling firm: Megadyne Medical Products, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-06-01
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K021077 — MEGA 2000 SOFT PATIENT RETURN ELECTRODE PADMegadyne Medical Products, Inc.·cleared 2002-04-17

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

MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery

Reason for recall

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

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