Recall Z-1920-2024— Megadyne Medical Products, Inc.

Name: FDA recall Z-1920-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-08

Class I · Ongoing

Class I FDA medical device recall by Megadyne Medical Products, Inc., initiated 2024-05-08. It names one FDA 510(k) clearance: K080741. Product: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.. Reason: Reports of patient burns..

Recalling firm: Megadyne Medical Products, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-05-08
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K080741 — MEGA SOFT REUSABLE PATIENT RETURN ELECTRODEMegadyne Medical Products, Inc.·cleared 2008-12-16

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 Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.

Reason for recall

Reports of patient burns.

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