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Megadyne Medical Products, Inc.

Complete recall history across all FDA and CPSC categories — 20 total recalls

Megadyne Medical Products, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (20)

FDA medical device enforcement actions by Megadyne Medical Products, Inc.

Date Product Reason Class
Jun 17, 2024 Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Prod... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitiga... Class I
Jun 17, 2024 Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGA... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitiga... Class I
Jun 17, 2024 Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product N... To limit the use of the Mega Soft Pads to patients aged 12 or older to mitiga... Class I
May 8, 2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Retur... Reports of patient burns. Class I
Dec 8, 2023 Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reu... Affected product codes are now limited to use in patients age 12 years or old... Class I
Dec 8, 2023 Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode... Affected product codes are now limited to use in patients age 12 years or old... Class I
Dec 8, 2023 Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode... Affected product codes are now limited to use in patients age 12 years or old... Class I
Dec 8, 2023 Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Elec... Affected product codes are now limited to use in patients age 12 years or old... Class I
Jun 15, 2023 MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handsw... An issue with the Suction Coagulator product family may lead to fluid ingress... Class II
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during elect... Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where devic... Class I
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where devic... Class I
May 15, 2018 MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715 If two devices are plugged into the same channel/port in the generator, both ... Class II
Feb 27, 2014 Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Di... Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Su... Class II
Aug 7, 2013 E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. ... Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire lapr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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