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Philips North America Llc

Philips North America Llc Recalls

All product recalls associated with Philips North America Llc.

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Recall Summary

Total Recalls

1000

Past Year

1000

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 2421–2440 of 21320 recalls

Ingenia 1.5T MR Systems (Philips) – Electrical Hotspot Risk (2024)

Fire/Burn Risk

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

High

FDAMay 3, 2024Nationwide• Philips North America Llc

ADVANTA VXT Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Low

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

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Low

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Low

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

Lawnmowers and Pressure Washer Engines (Honda) – mechanical issue (2024)

This recall involves Honda HRN216 and HRX217K6 lawnmowers, and GCV170/200 G5B general-purpose engines used in power washers and lawnmower replacement engines. The gas-fueled walk-behind lawnmowers are red and black with "HONDA" written on the clipping collection bag. The model and serial number are printed on a label located on the upper rear of the mower deck. The pressure washer engines are mounted on various original equipment manufacturer frames. The serial number of the engine is engraved on a flat spot on the engine. The lawnmower replacement engines are used to replace the existing engines on the Honda HRN216 and HRX217K6 lawnmowers. The serial number of the lawnmower replacement engine is engraved on a flat spot on the engine.

High

CPSCMay 2, 2024Nationwide• American Honda Motor Co. Inc., of Torrance, California

Arctic Cat Snowmobiles (Arctic Cat) – Laceration Risk (2024)

Laceration Risk

This recall involves all model year 2017-2021 Arctic Cat 8000 and 9000 series snowmobiles, and certain model year 2022 Arctic Cat 8000 series snowmobiles with last 8 digits of the VIN between: NT808000 and NT808150 and between NT100101 and NT101060. The recalled snowmobiles were produced in a variety of color combinations. "Arctic Cat" is printed on the sides of the vehicle and on the back snow-flap area.

High

CPSCMay 2, 2024Nationwide• Arctic Cat, of Thief River Falls, Minnesota

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

TabloCart (Outset Medical) – Cord Connector Defect (2024)

A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or the associated connector power entry module, which may lead to transient delay in treatment or blistering to the user.

High

FDAApr 30, 2024Nationwide• Outset Medical, Inc.

Agilis NxT Steerable Introducer (St. Jude) – Short Dilators (2024)

One lot of product has dilators that are too short and will not extend outside the introducer sheath.

Moderate

FDAApr 30, 2024Nationwide• St. Jude Medical

ZOLL 731 Ventilator (ZOLL) – MRI Safety Information (2024)

Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy

Low

FDAApr 30, 2024Nationwide• ZOLL Medical Corporation

BSM-3000 Bedside Monitor (Nihon Kohden) – SpO2 Alarm (2024)

Due to software issue the device may give false "SpO2 Probe Failure" alarm

Moderate

FDAApr 29, 2024Nationwide• Nihon Kohden America Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

O-arm O2 Imaging System (Medtronic) – Electrical Component (2024)

Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance.

High

FDAApr 26, 2024Nationwide• Medtronic Navigation, Inc.-Littleton

Micro Bird G5 School Bus – Power Steering Line (2024)

Corp. Mirco Bird, Inc. (Micro Bird) is recalling certain 2019-2022 G5 school buses. An inadequate connection between the power steering pressure line and the brake hydroboost unit may result in a sudden loss of power steering fluid.

High

NHTSAApr 26, 2024Nationwide• MICRO BIRD

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Class IIModerate

FDAApr 26, 2024Nationwide• Rubicon Research Private Limited

Methylprednisolone Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Potential for black particulates in the drug product.

Class IIModerate

FDAApr 25, 2024Nationwide• Sagent Pharmaceuticals

EsophaCap (Lucid Diagnostics) – Sponge Detachment (2024)

The EsophaCap sponge may be at increased risk of detaching from the string during removal of the device from the patient, particularly at the lower esophageal sphincter at the gastroesophageal junction or the upper esophageal sphincter between the pharynx and the esophagus, which is the narrowest part of the alimentary canal.

High

FDAApr 24, 2024Nationwide• Lucid Diagnostics, Inc.