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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

353

Class I (Serious)

Most Recent

Jan 2026

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 581–600 of 3680 recalls

MRI Vantage Orian Systems (Canon Medical) – Cable Fastening Issue (2024)

Fire/Burn Risk

The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

High

FDAMay 10, 2024AL, AZ, AR +35 more• Canon Medical System, USA, INC.

HistoCore Arcadia H (Leica) – Smoke and Fire Hazard (2024)

Fire/Burn Risk

An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

High

FDAMay 10, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

Cataract Pack Kit (American Contract Systems) – Sterilization Issue (2024)

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Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Hand Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Biopsy Drape Pack (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Gyn Laparoscopy Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Special Procedure Pack (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Spine Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Extremity Convenience Kit (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

Laparoscopy Litho Pack (American Contract Systems) – Sterilization Issue (2024)

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

High

FDAMay 6, 2024Nationwide• American Contract Systems, Inc.

First Street Yogurt Pretzels (Smart & Final) – Salmonella risk (2024)

Salmonella

Potential Salmonella contamination.

Class IHigh

FDAMay 6, 2024CA, WA• WESTERN MIXERS PRODUCE & NUTS, I

Cerene Cryotherapy Device (Channel Medsystems) – Error Code Issue (2024)

Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).

Low

FDAMay 3, 2024Nationwide• Channel Medsystems, Inc.

Leaf Blowers and Vacuums (Generac) – laceration hazard (2024)

Laceration Risk

This recall involves DR Power Equipment walk-behind leaf blowers and vacuums, and tow-behind leaf vacuums with the following model numbers: Unit Type Model Numbers Walk-Behind Leaf Blower LB16020DEN LB16020DMNR LB16020DENR LB18020DEN LB16020DMN LB18020DENR Walk-Behind Leaf Vacuum WL33006DMN WL35008DENSD WL33006DMNR WL35008DMN WL35008DEN WL35008DMNR WL35008DENR WL35008DMNSD Tow-Behind LL3 LL31027DMN LL33032DEN LL33032DENR LL33032DENSD LL33032DMN LL35045DEN LL35045DMN LL35045DMNR LL37045DEN LL37045DMN LL37045DMNR LL37045DMNSD LL37060DEN LL37060DENR Tow-Behind LL2 LL21009DMN LL21009DMNR LL21009DMNSD LL23009DEN LL23009DENR LL23009DMN LL25013DEN LL25013DENR LL25013DENSD LL25013DMN LL25013DMNR LL25013DMNSD LL27016DEN LL27016DENR LL27016DENSD LL27016DMN LL27016DMNR LL27016DMNSD Additional LL2 Models *Note: These model numbers may or may not have spaces as printed on the data tags. LLVX13EDTDV3BF1 LLVX13EDTDVBBF1 LLVX13ENTDVBBF3 LLVX13MDTDV3BF0 LLVX13MDTDV3BF1 LLVX13MDTDVBBF1 LLVX13MNTDV3BF3 LLVX13MNTDVBBF3 LLVX16E LLVX16EDTDV3BF1 LLVX16EDTDVBBF1 LLVX16ENTDV2BF3 LLVX16ENTDV3BF3 LLVX16ENTDVBBF3 LLVX16MDTDV2BF1 LLVX16MDTDV3BF1 LLVX16MDTDVBBF1 LLVX16MNTDV2BF3 LLVX16MNTDV3BF3 LLVX16MNTDVBBF3 LLVX9AMDTDVBBF3 LLVX9AMNTDVBBF3 LLVX9GMNTDVBBF3 LLVXX9EDTDV3BF1 LLVXX9EDTDVBBF1 LLVXX9ENTDV3BF3 LLVXX9ENTDVBBF3 LLVXX9MDTDV3BF1 LLVXX9MDTDVBBF1 LLVXX9MNTDV3BF3 LLVXX9MNTDVBBF3 LLVXX9MNTDVBTF3 DR is printed on the motor housing. The model number on the walk-behind leaf blower is located on the top at the back of the blower housing. The model number on the walk-behind leaf vacuum is located on the front right side of the unit behind the wheel. The model number on the tow-behind leaf vacuum is on the impeller housing beside the engine.

High

CPSCMay 2, 2024Nationwide• Generac Power Systems Inc., of Waukesha, Wisconsin

Interventional Hemodynamic Software (Philips) – Data Sync (2024)

Potential for pressure wave data synchronization from two devices may not be correct.

Moderate

FDAMay 2, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

D*Clot HD Thrombectomy System (Mermaid Medical) – Bubble Leak (2024)

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

Moderate

FDAMay 1, 2024Nationwide• Mermaid Medical A/S Frydensbergvej 25 Stenlose Denmark

Monoject Syringe (McKesson) – Distribution Error (2024)

Quarantined product was inadvertently distributed

Low

FDAApr 23, 2024Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Prucka 3 Amplifier (GE Medical) – capacitor failure (2024)

Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in transient oscillations on the display and inability to view surface and intracardiac ECG waveforms.

Moderate

FDAApr 22, 2024Nationwide• GE Medical Systems Information Technologies Inc

Mi1250 SYNCHRONY 2 (MED-EL) – internal electronics crack (2024)

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

Moderate

FDAApr 18, 2024NC• MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria

CARDIOHELP-i System (Maquet) – patient leakage current (2024)

The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

High

FDAApr 15, 2024Nationwide• Maquet Medical Systems USA

MyoSPECT System (GE Medical) – lead cover handle risk (2024)

There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the weight of the cover.

Moderate

FDAApr 15, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel