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Canon Medical System, USA, INC.

Canon Medical System, USA, INC. Recalls

All product recalls associated with Canon Medical System, USA, INC..

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Recall Summary

Total Recalls

1000

Past Year

581

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 2101–2120 of 10937 recalls

Canon Aplio Ultrasound (Canon) – Stress Echo Termination Problem (2022)

After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

Moderate

FDASep 29, 2022AR, CA, CO +20 more• Canon Medical System, USA, INC.

K-ASSAY IgA Immunoturbidimetric (Kamiya) – Reagent Cloudiness (2022)

IgA Reagent may start showing cloudiness over time, which can affect assay performance.

Low

FDASep 28, 2022Nationwide• Kamiya Biomedical Company, LLC

biokitHSV-2 Rapid Test (Biokit) – False Positive Risk (2022)

HSV-2 rapid test may report false positive results.

High

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Page 106 of 547Next

FDA

Sep 28, 2022

Nationwide

• Biokit, S.A. Avinguda De Can Montcau 7 (Barcelona) Llica D'Amunt Spain

Acyclovir Sodium Injection (AuroMedics) – particulate matter (2022)

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

Class IIModerate

FDASep 26, 2022Nationwide• AuroMedics Pharma LLC

Tranexamic Acid Injection (AuroMedics) – metal contamination (2022)

Presence of Particulate Matter: Piece of metal found in a vial

Class IIILow

FDASep 26, 2022Nationwide• AuroMedics Pharma LLC

Hamilton-C6 (Hamilton Medical) – Screen Backlight Problem (2022)

Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.

FDASep 22, 2022Nationwide• Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland

Bunk Bed Ladders (Canyon Furniture) – Entrapment Risk (2022)

This recall involves ladders sold as part of a furniture set, including Cottage Colors and Canyon Lake bunk bed configurations that include desk- or dresser-top hutches. The recalled ladders were sold in various combinations with bunk beds and hutches. The ladders have the following SKU numbers, which are printed on a label on the underside of a ladder step. This recall includes only ladders sold with the Canyon Lake and Cottage Colors bunk bed configurations that include a desk- or dresser-top hutch. Brand Name Color of Ladder SKU Canyon Lake Java ladder 35834008 Ash gray ladder 35834010 Cottage Colors White ladder 36428008 Black ladder 36428010 Gray ladder 36428022

CPSCSep 22, 2022Nationwide• Montecitos Manufacturing, of Mexico

Skinny Guy Camper (Skinny Guy) – LP Gas Fitting Risk (2022)

Fire/Burn Risk

Skinny Guy Campers LLC (Skinny Guy Camper) is recalling certain Model 6.5 Campers. The quick disconnect fittings in the LP gas system may be cracked, causing a gas leak.

NHTSASep 21, 2022Nationwide• SKINNY GUY CAMPER

MiniMed Insulin Pump (Medtronic) – Cybersecurity Vulnerability (2022)

Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

FDASep 20, 2022AL, AK, AZ +49 more• Medtronic MiniMed

MiniMed Insulin Pump (Medtronic) – Cybersecurity Vulnerability (2022)

FDASep 20, 2022AL, AK, AZ +49 more• Medtronic MiniMed

Clonidine Hydrochloride Tablets (UNICHEM) – Product Mix-up (2022)

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

Class IIILow

FDASep 19, 2022Nationwide• UNICHEM PHARMACEUTICALS USA INC

Dutch Red Potatoes (Melissa's) – Undeclared Egg (2022)

Dutch Red Potatoes were packed with a Dijon Mustard Sauce packet that did not declare the allergen of egg.

Class IHigh

FDASep 19, 2022Nationwide• World Variety Produce Inc dba Melissa's

Vacutainer Tube (Becton Dickinson) – Methanol Interference (2022)

The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.

FDASep 15, 2022Nationwide• Becton Dickinson & Company

Disc Preparation Instruments (Alphatec) – Manufacturing Error (2022)

Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.

FDASep 14, 2022CA• Alphatec Spine, Inc. 1950 Camino Vida Roble

NovoTHOR Gen 2.5 (Thor) – Gas Strut Detachment (2022)

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

FDASep 13, 2022Nationwide• Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom

NOVO GEN 2.0 XL Bed (Thor) – Gas Strut Detachment (2022)

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

FDASep 13, 2022Nationwide• Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom

NovoTHOR Gen 2.0 (Thor) – Gas Strut Detachment (2022)

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

FDASep 13, 2022Nationwide• Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom

NovoTHOR Gen 2.5 XL (Thor) – Gas Strut Detachment (2022)

Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.

FDASep 13, 2022Nationwide• Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom

Rover Mobile X-Ray System (Micro-X) – DAP Meter Calibration Error (2022)

Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

FDAAug 31, 2022Nationwide• Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia

Pinnacle3 Radiation Planning System (Philips) – Dose Export Error (2022)

When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

FDAAug 30, 2022CA, FL, GA +18 more• Philips Medical Systems (Cleveland) Inc