Manufacturer

Megadyne Medical Products, Inc.

20 recalls in our database name Megadyne Medical Products, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 20
Critical: 7
Severe: 10
Most recent: 2024-07-10

Of the 20 recalls from Megadyne Medical Products, Inc. we have scored against our rubric, 7 (35%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–20 of 20

SevereFDA (Devices)·Z-2249-2024·2024-07-10
MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Burn Risk
Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 12 and older.
Product
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2250-2024·2024-07-10
Reusable Patient Return Electrode Recalled Due to Burn Risk
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrodes are recalled due to an identified risk of patient burns. Use should be restricted to patients aged 12 or older.
Product
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2248-2024·2024-07-10
Megadyne MEGA 2000 Patient Return Electrode recalled for burn risk
Megadyne is recalling the MEGA 2000 Patient Return Electrode due to identified potential risk of patient burns. Use is now restricted to patients aged 12 or older.
Product
Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Model/Catalog Number: 0800 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1920-2024·2024-06-12
Pediatric Patient Return Electrode Recalled for Reported Patient Burns
Megadyne Medical Products is recalling its MEGA SOFT Pediatric Patient Return Electrode due to reports of patient burns during electrosurgical use. Approximately 1,270 units distributed worldwide are affected.
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.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0600-2024·2024-01-03
Megadyne Patient Return Electrode Recalled Due to Serious Burn Injury Reports
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.
Product
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0599-2024·2024-01-03
Megadyne MEGA SOFT Return Electrode Recalled for Serious Burn Injuries
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.
Product
Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0597-2024·2024-01-03
MEGADYNE MEGA SOFT Return Electrode Recalled Due to Reported Patient Burn Injuries
Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.
Product
Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0598-2024·2024-01-03
Megadyne Patient Return Electrodes Recalled Due to Serious Burn Risk
Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.
Product
Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2023·2023-08-09
MEGADYNE Suction Coagulators recalled for fluid ingress causing device malfunction
Megadyne Medical Products is recalling 241,457 MEGADYNE Suction Coagulators due to fluid ingress into the handpiece, which may cause unintended activation, failure to activate, or self-activation during surgical procedures.
Product
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Pr
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1994-2023·2023-07-05
MEGADYNE MEGA 2000 Patient Return Electrode Recalled Due to Patient Burns
The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode due to reports of patient burns during electrosurgical procedures. All units distributed nationwide are affected.
Product
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2000-2023·2023-07-05
MEGADYNE MEGA SOFT Return Electrode Recalled for Burns During Surgical Procedures
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns that occurred during electrosurgical procedures.
Product
MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1999-2023·2023-07-05
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode Recalled for Patient Burns
Megadyne Medical Products is recalling 21,100 units of MEGA SOFT Universal Plus Patient Return Electrodes used in electrosurgery. The FDA Class I recall follows reports of patient burns during surgical procedures.
Product
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1997-2023·2023-07-05
Pediatric Patient Return Electrode Recalled for Reported Burns in Surgery
Megadyne Medical Products recalls approximately 21,100 MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes (Model 0840) due to reports of patient burns during electrosurgical procedures.
Product
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1996-2023·2023-07-05
MEGADYNE MEGA SOFT Patient Return Electrode Recalled for Reported Patient Burns
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode used in electrosurgery due to reports of patient burns during surgical procedures.
Product
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1995-2023·2023-07-05
MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Patient Burn Hazard
Megadyne Medical Products is recalling 21,100 MEGADYNE MEGA SOFT Reusable Patient Return Electrodes nationwide due to reports of patient burns during electrosurgical procedures.
Product
MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1998-2023·2023-07-05
Patient Return Electrode Recalled Due to Burn Reports During Surgery
Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.
Product
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2001-2023·2023-07-05
Megadyne Mega Soft Universal Patient Return Electrode Recalled for Burn Risk
Megadyne Medical Products is recalling 21,100 MEGA SOFT electrosurgery patient return electrodes distributed nationwide due to reports of patient burns during surgical procedures.
Product
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2792-2018·2018-08-22
MegaPower Electrosurgical Generator Recalled for Potential Patient Burns
Megadyne Medical Products is recalling 8,380 MegaPower Electrosurgical Generators because plugging two devices into the same port can activate both, potentially causing patient burns.
Product
MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2014·2014-03-19
Megadyne Recalls Suction Coagulators Due to Self-Activation Risk
Megadyne Medical Products is voluntarily recalling specific lots of Hand Control 12FR Suction Coagulators because they may self-activate when connected to a generator.
Product
Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2097-2013·2013-09-04
Megadyne Recalls E-Z Clean Laparoscopic Electrodes Due to Insulation Breach
Megadyne Medical Products is recalling specific lots of E-Z Clean Disposable Laparoscopic Electrodes due to potential insulation breaches.
Product
E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is
Category
Medical Device
Distribution
11 states