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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands Recalls

All product recalls associated with PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands.

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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 1321–1340 of 21319 recalls

Azurion 7 M12 (Philips) – Patient Fall Risk (2025)

Possibility of the patient falling from the table related to the mattress used on the patient table.

Moderate

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Duloxetine Capsules (Harvard Drug Group) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Class IIModerate

FDAJan 13, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Allura Xper FD20 (Philips) – Patient Fall Risk (2025)

Possibility of the patient falling from the table related to the mattress used on the patient table.

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Moderate

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

AlluraXperFD20/15 (Philips) – Safety Issue (2025)

Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel

High

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Azurion 7 M12 (Philips) – Safety Issue (2025)

High

FDAJan 13, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intact Vascular Tack System (Spectranetics) – Artery Treatment (2025)

Laceration Risk

Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

High

FDAJan 10, 2025Nationwide• Spectranetics Corporation

Granix Injection (Teva) – Failed Stability Test (2025)

Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

Class IIModerate

FDAJan 10, 2025Nationwide• Teva Pharmaceuticals USA, Inc

A820 myPTM Software (Medtronic) – App Interaction Delay (2025)

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

Moderate

FDAJan 9, 2025Nationwide• Medtronic Neuromodulation

CircuitGuard Bacterial Filter (Kung Shin) – Airflow Blockage (2025)

The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

Very High

FDAJan 9, 2025Nationwide• Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan

CircuitGuard ThermoFlo (Kung Shin) – Airflow Blockage (2025)

Very High

FDAJan 9, 2025Nationwide• Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan

MSOT Acuity Echo (Ithera) – Safety Instruction (2025)

The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

Moderate

FDAJan 8, 2025Nationwide• Ithera Medical Gmbh Zielstattstr. 13 Munich Germany

Rapid fFN Specimen Tube (Hologic) – Collection Kit Issue (2025)

Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.

High

FDAJan 8, 2025Nationwide• Hologic, Inc.

Clobazam Tablets (Amerisource) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDAJan 7, 2025Nationwide• Amerisource Health Services LLC

Guaifenesin Codeine Solution (PAI Holdings) – Superpotent Preservative (2025)

Superpotent; sodium benzoate preservative

Class IIILow

FDAJan 7, 2025OH• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Sysmex PS-10 System (Sysmex) – False Result Risk (2025)

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

High

FDAJan 6, 2025Nationwide• Sysmex America, Inc.

Peach Mango Sorbet (My Mochi) – Undeclared Egg (2025)

Undeclared Allergen

Frozen Peach Mango Sorbet contains undeclared allergen (egg)

Class IHigh

FDAJan 6, 2025Nationwide• The Mochi Ice Cream Company

Irix-A Fusion System (Xtant) – Incorrect Expiration (2025)

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Low

FDAJan 3, 2025Nationwide• XTANT Medical Holdings, Inc

Brasseler ESR Endodontic File (US Endodontics) – Radiation Exposure (2025)

Due to devices being irradiated above the established specification which my result in package integrity issues.

Moderate

FDAJan 2, 2025Nationwide• US Endodontics, LLC

ARTIS One X-Ray System (Siemens) – First Release Issue (2025)

A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.

High

FDAJan 2, 2025IN• SIEMENS MEDICAL SOLUTIONS USA, INC

Metformin ER Tablets 500mg (Granules) – foreign tablet found (2024)

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Class IIModerate

FDADec 30, 2024IN, OH• Granules Pharmaceuticals Inc.