RecallRadar

FDA Device recall Z-1920-2024

MEGADYNE MEGA SOFT Pediatric Patient Return Electrode

On 2024-06-12 the FDA classified a Class I recall of MEGADYNE MEGA SOFT Pediatric Patient Return Electrode by Megadyne Medical Products, citing reports of patient burns.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1920-2024
ClassificationClass I
Statusongoing
Initiated2024-05-08
Published2024-06-12
Last updated2026-09-13 11:57 UTC
CompanyMegadyne Medical Products
DistributionUS

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.

Identifiers

code_infoModel Number: 0840; UDI-DI: 10614559103395; Lot Number: All distributed lot numbers.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1920-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.