Chrysalis Intelligence · Sponsors · Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.

Draper, UT, US · 4 510(k) clearances · 17 recalls (16 Class I)

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Total clearances
4
2020-03-24 → 2024-07-12
Last 12 months
0
Product codes
2
Most recent
2024-07-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 3 2024-07-12
FYD Apparatus, Exhaust, Surgical Class II General, Plastic Surgery 1 2020-06-26
Safety

Recalls (17)

Class I (serious)
16
Risk of injury / death
Total recalls
17
Currently ongoing
17
Most recent
2024-06-17
DateSeverityStatusRecall # ProductCodeReason
2024-06-17 Class I Ongoing Z-2250-2024 Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusabl… — To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
2024-06-17 Class I Ongoing Z-2249-2024 Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient … — To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
2024-06-17 Class I Ongoing Z-2248-2024 Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode … — To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
2024-05-08 Class I Ongoing Z-1920-2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50… — Reports of patient burns.
2023-12-08 Class I Ongoing Z-0600-2024 Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M… — 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 thir…
2023-12-08 Class I Ongoing Z-0599-2024 Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega S… — 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 thir…
2023-12-08 Class I Ongoing Z-0598-2024 Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega S… — 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 thir…
2023-12-08 Class I Ongoing Z-0597-2024 Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode — 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 thir…
2023-06-15 Class II Ongoing Z-2257-2023 MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product … — An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-…
2023-06-01 Class I Ongoing Z-2001-2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-2000-2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-1999-2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-1998-2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-1997-2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-1996-2023 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-1995-2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
2023-06-01 Class I Ongoing Z-1994-2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery — Firm has received reports of patient burns in surgical procedures where device was used.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-07-12 K233644 Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) GEI Class II General, Plastic Surgery
2022-01-21 K213696 ETHICON Megadyne Electrosurgical Generator GEI Class II General, Plastic Surgery
2020-06-26 K200250 Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor FYD Class II General, Plastic Surgery
2020-03-24 K193145 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch GEI Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence