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Megadyne

by Megadyne Medical Products, Inc. 21 variants

Ref M2K08

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

8 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0614559a00005BR Basic UDI-DI 10614559105245UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10614559105245 UDI-DI Date5 Sep 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

8 recalls · 8 ongoing · FDA

    • Ongoing Z-2248-2024 FDA Class I initiated 17 Jun 2024

    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.

    • Ongoing Z-1920-2024 FDA Class I initiated 8 May 2024

    Reports of patient burns.

    • Ongoing Z-0597-2024 FDA Class I initiated 8 Dec 2023

    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.

  • 5 recalls, same reason

    • Ongoing Z-2000-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-1997-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-1999-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-2001-2023 FDA Class I initiated 1 Jun 2023
    • Ongoing Z-1998-2023 FDA Class I initiated 1 Jun 2023

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Megadyne EUDAMED
Mega Soft GUDID
Generic Name
Electrosurgical return lead
Device Name
MEGADYNE Cable
Model / Ref / Catalog
M2K08
Primary DI / UDI-DI
10614559105245
Basic UDI-DI
0614559a00005BR
Direct Marketing DI
10614559105245
510(k) Number
FDA Product Code
GEI
EMDN Code
Z12010980 Electrosurgery instruments - hardware accessories
GMDN Term
Electrosurgical return lead
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017046
Authorised representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No