Electrode, Cutaneous
Neurology · 21 CFR 882.1320
Recent MDR events
529 adverse event reports on file
- BISJul 30, 2026MalfunctionCovidien2936999-2026-00298
- BISJul 29, 2026MalfunctionCovidien2936999-2026-00296
- BIOMET SPINALPAK / ORTHOPAKJul 22, 2026InjuryEbi, Llc.0002242816-2026-00093
- BIOMET SPINALPAK / ORTHOPAKJul 21, 2026InjuryEbi, Llc.0002242816-2026-00090
- BISJul 18, 2026MalfunctionCovidien2936999-2026-00286
- BIOMET SPINALPAK / ORTHOPAKJul 13, 2026InjuryEbi, Llc.0002242816-2026-00083
- BIOMET SPINALPAK / ORTHOPAKJul 10, 2026InjuryEbi, Llc.0002242816-2026-00082
- BIOMET SPINALPAK / ORTHOPAKJul 1, 2026InjuryEbi, Llc.0002242816-2026-00081
- BISJun 24, 2026MalfunctionCovidien2936999-2026-00254
- BISJun 24, 2026MalfunctionCovidien2936999-2026-00259
Event type breakdown
Recalls
20 recall events for this product code
- Coapt LLCOpen, ClassifiedOct 31, 2023
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Z-0203-2024 · View FDA record ↗ - Coapt LLCOpen, ClassifiedOct 31, 2023
Coapt ControlSeal Electrode, cutaneous EMG Electrode
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Z-0204-2024 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1595-2022 · View FDA record ↗ - Medtronic Navigation, Inc.TerminatedMay 9, 2014
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Z-1583-2014 · View FDA record ↗ - Medtronic Navigation, Inc.TerminatedMay 9, 2014
MOUSE 9732721 STERILE O-ARM 10PK
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Z-1588-2014 · View FDA record ↗ - NAImco Inc dba Richmar IncTerminatedFeb 14, 2013
Cloth electrodes with Carbon construction:
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Z-0815-2013 · View FDA record ↗ - NAImco Inc dba Richmar IncTerminatedFeb 14, 2013
Cloth electrodes with Silver-Carbon construction:
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Z-0816-2013 · View FDA record ↗ - NAImco Inc dba Richmar IncTerminatedFeb 14, 2013
Foam Electrodes with Carbon construction:
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Z-0817-2013 · View FDA record ↗ - NAImco Inc dba Richmar IncTerminatedFeb 14, 2013
Foam electrodes with Silver-Carbon construction:
Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
Z-0818-2013 · View FDA record ↗ - Covidien LLC dba Uni-PatchTerminatedDec 10, 2012
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a
Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Z-0498-2013 · View FDA record ↗
Registered firms
484 firms currently registered for this product code
Therabody, Inc.
Los Angeles, CA, US
Ceribell, Inc.
Sunnyvale, CA, US
Pine Moon Electronics Co., Ltd.
SHENZHEN CITY Guangdong, CN
Rhythmlink International, Llc
Columbia, SC, US
Vive Health Llc
Naples, FL, US
Cardinal Health 200, Llc
Waukegan, IL, US
China Qingdao Bright Medical Manufacturing Co.,ltd.
Qingdao Shandong, CN
Ampcare, Llc
Fort Worth, TX, US
Ambu Sdn.bhd.
PENANG Pulau Pinang, MY
Djo, Llc
Carlsbad, CA, US
Conmed Corporation
Utica, NY, US
Pain Management Technologies
AKRON, OH, US
Intelligent Hearing Systems Corp.
MIAMI, FL, US
Interx Technologies
Plano, TX, US
Ottobock Se & Co. Kgaa Formerly Known As Otto Bock Healthcare Gmbh
DUDERSTADT Lower Saxony, DE
Steripack Usa (limited) Llc
Lakeland, FL, US
Conmed Corporation
WESTBOROUGH, MA, US
Alliance Neurodiagnostics, Llc, D/b/a Stratus
Irving, TX, US
Natus Neurology Incorporated
Middleton, WI, US
Masimo Corporation
Irvine, CA, US
Accelerated Care Plus Corp.
RENO, NV, US
510(k) clearances
439 clearances for this product code
- Ambu A/SJul 14, 2026
K260578 · Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- Cadwell Industries, Inc.Jun 26, 2026
K261442 · Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
- Biowave CorporationJun 3, 2026
K261522 · BioWave BioWraps
- Elde Medikal Sanayi ve Ticaret Anonim SirketiMay 8, 2026
K253237 · Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
- Technomed EuropeMay 7, 2026
K254183 · MR Conditional Cup Electrodes
- Dongguan Tutamen Metalwork Co., Ltd.May 1, 2026
K252439 · Tutamen Self Adhesive Electrodes
- Otto Bock Healthcare Products GmbHApr 22, 2026
K253256 · myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
- Ceribell, Inc.Apr 3, 2026
K260363 · Ceribell Brain Monitor Headband