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TPLC
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Device
disinfectant, medical devices
Product Code
LRJ
Regulation Number
880.6890
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
18
18
2015
15
15
2016
13
13
2017
6
6
2018
15
15
2019
12
12
2020
73
73
2021
473
473
2022
171
171
2023
95
95
2024
73
73
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
324
324
Adverse Event Without Identified Device or Use Problem
288
288
Patient-Device Incompatibility
113
113
Decrease in Pressure
86
86
Appropriate Term/Code Not Available
37
37
Device Emits Odor
28
28
Defective Component
20
20
Nonstandard Device
16
16
Pressure Problem
13
13
Product Quality Problem
11
11
Improper or Incorrect Procedure or Method
8
8
Device Contamination with Chemical or Other Material
8
8
Installation-Related Problem
7
7
Chemical Problem
6
6
Use of Device Problem
5
5
Contamination /Decontamination Problem
5
5
Defective Device
5
5
Patient Device Interaction Problem
4
4
Device Disinfection Or Sterilization Issue
4
4
Device Expiration Issue
4
4
Break
4
4
Material Discolored
4
4
Device Reprocessing Problem
3
3
Contamination
3
3
Material Fragmentation
3
3
Particulates
3
3
Chemical Spillage
3
3
Device Rinsing Issue
3
3
Device Operates Differently Than Expected
3
3
Output Problem
3
3
Material Deformation
3
3
Material Integrity Problem
2
2
Gas/Air Leak
2
2
Improper Chemical Reaction
2
2
Inadequate Instructions for Non-Healthcare Professional
2
2
Fungus in Device Environment
2
2
Inaccurate Delivery
1
1
Fumes or Vapors
1
1
Biocompatibility
1
1
Material Puncture/Hole
1
1
Device Appears to Trigger Rejection
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Too Rigid or Stiff
1
1
Shelf Life Exceeded
1
1
Unexpected Therapeutic Results
1
1
Fire
1
1
Unintended Collision
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Labelling, Instructions for Use or Training Problem
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Melted
1
1
Failure to Disinfect
1
1
Material Erosion
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Contamination With Biological Material
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Device Damaged by Another Device
1
1
Device Packaging Compromised
1
1
Device Unsafe to Use in Environment
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Environmental Compatibility Problem
1
1
Failure to Shut Off
1
1
No Fail-Safe Mechanism
1
1
Protective Measures Problem
1
1
Misassembly by Users
1
1
No Apparent Adverse Event
1
1
Unexpected Shutdown
1
1
Failure to Clean Adequately
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
268
268
Cough
163
163
Rash
161
161
Dyspnea
111
111
Headache
73
73
Skin Inflammation/ Irritation
71
71
Unspecified Respiratory Problem
46
46
Sore Throat
46
46
Pneumonia
32
32
Bronchitis
29
29
Asthma
28
28
Itching Sensation
27
27
Skin Burning Sensation
27
27
Wheezing
23
23
Reaction
23
23
Chest Pain
23
23
No Known Impact Or Consequence To Patient
22
22
Bacterial Infection
21
21
Burning Sensation
21
21
Pain
20
20
Sneezing
20
20
Unspecified Infection
17
17
Respiratory Tract Infection
17
17
Blister
17
17
No Clinical Signs, Symptoms or Conditions
17
17
Irritation
16
16
Dizziness
16
16
Inflammation
15
15
No Code Available
15
15
Insufficient Information
13
13
Nausea
13
13
Skin Infection
12
12
Discomfort
11
11
Fever
11
11
Fatigue
9
9
Erythema
9
9
Aspiration/Inhalation
9
9
Chemical Exposure
9
9
Nasal Obstruction
9
9
Fungal Infection
8
8
Swelling
8
8
Skin Irritation
7
7
Hypersensitivity/Allergic reaction
7
7
Vomiting
6
6
Sleep Dysfunction
6
6
Caustic/Chemical Burns
6
6
Epistaxis
6
6
Eye Pain
5
5
Swelling/ Edema
5
5
Viral Infection
5
5
Malaise
5
5
Cancer
5
5
Respiratory Distress
5
5
Chest Tightness/Pressure
4
4
Dry Mouth
4
4
Localized Skin Lesion
3
3
Nodule
3
3
Swollen Lymph Nodes/Glands
3
3
High Blood Pressure/ Hypertension
3
3
Hemorrhage/Bleeding
3
3
Apnea
3
3
Burn(s)
3
3
Eye Injury
3
3
Dry Eye(s)
2
2
Hearing Impairment
2
2
Myocardial Infarction
2
2
Memory Loss/Impairment
2
2
Red Eye(s)
2
2
Skin Discoloration
2
2
Chronic Obstructive Pulmonary Disease (COPD)
2
2
Complaint, Ill-Defined
2
2
Ulcer
2
2
Dysphasia
2
2
Vertigo
2
2
Blurred Vision
2
2
Discharge
2
2
No Information
2
2
Weight Changes
2
2
No Patient Involvement
2
2
Choking
2
2
Lethargy
2
2
Contact Dermatitis
2
2
Unspecified Eye / Vision Problem
2
2
Unspecified Tissue Injury
2
2
Alteration in Body Temperature
1
1
Unspecified Ear or Labyrinth Problem
1
1
Renal Impairment
1
1
Osteomyelitis
1
1
Drug Resistant Bacterial Infection
1
1
Burn, Thermal
1
1
Palpitations
1
1
Respiratory Failure
1
1
Numbness
1
1
Irritability
1
1
Sensitivity of Teeth
1
1
Skin Inflammation
1
1
Diaphoresis
1
1
Tissue Breakdown
1
1
Alteration In Body Temperature
1
1
Superficial (First Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-22-2024
2
MEDLINE INDUSTRIES, LP - Northfield
II
Aug-02-2022
3
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-01-2022
4
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
5
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
6
Medtrol, Inc.
II
Jun-22-2010
7
Metrex Research, LLC.
II
Mar-03-2017
8
Metrex Research, LLC.
II
Aug-24-2012
9
Wexford Labs Inc
II
Nov-19-2013
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