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Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 20 FDA device recalls.

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DateProductReasonClassFirm
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 mitigate the potential ris... Class I Megadyne Medical Products, Inc.
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 mitigate the potential ris... Class I Megadyne Medical Products, Inc.
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 mitigate the potential ris... Class I Megadyne Medical Products, Inc.
May 8, 2024 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Retur... Reports of patient burns. Class I Megadyne Medical Products, Inc.
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 older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
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 older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
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 older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
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 older. Megadyne has rec... Class I Megadyne Medical Products, Inc.
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 into the handpiece.... Class II Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
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 device was used. Class I Megadyne Medical Products, Inc.
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 device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
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 device was used. Class I Megadyne Medical Products, Inc.
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 device was used. Class I Megadyne Medical Products, Inc.
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 devices activate. If... Class II Megadyne Medical Products, Inc.
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 Suction Coagulator wit... Class II Megadyne Medical Products, Inc.
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 laproscopic Electrode St... Class II Megadyne Medical Products, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.