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Philips North America

Philips North America Recalls

All product recalls associated with Philips North America.

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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 141–160 of 21319 recalls

Azurion R3.0 (Philips) – SSD Spacer Omission (2025)

Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.

Moderate

FDAOct 27, 2025Nationwide• Philips North America

Hemodialysis System Surdial DX (Nipro) – Screw Loosening Risk (2025)

Screw may loosen or fallout of Hemodialysis system

Moderate

FDAOct 27, 2025Nationwide• Nipro Medical Corporation

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class I

1...6 789 10...1066

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High

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Fresh Herbs (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

Sodium Chloride Injection (Otsuka) - Sterility Risk (2025)

Lack of Assurance of Sterility: Potential for flexible container leaks.

Class IIModerate

FDAOct 27, 2025Nationwide• Otsuka ICU Medical LLC

Vegetable Carton Label (Pacific International) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella.

Class IHigh

FDAOct 27, 2025AZ, CA, FL +5 more• Pacific International Marketing

5008X CAREsystem (Fresenius) – Software Anomaly Risk (2025)

Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.

Moderate

FDAOct 25, 2025LA, MA, MN• Fresenius Medical Care Holdings, Inc.

MAMMOMAT Revelation (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Moderate

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAMMOMAT Inspiration (Siemens) – Incorrect Table Installation (2025)

Moderate

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

Member's Mark Super Greens (MeriCal) – Salmonella Risk (2025)

Salmonella

Potential contamination of Salmonella Richmond

Class IHigh

FDAOct 24, 2025Nationwide• MeriCal, LLC

MAMMOMAT Fusion (Siemens) – Incorrect Table Installation (2025)

Moderate

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

Senographe Pristina (GE Medical) – X-Ray Warning Label Missing (2025)

Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).

Moderate

FDAOct 24, 2025Nationwide• GE Medical Systems, LLC

BD Kiestra Cuvette Array (Becton Dickinson) – Barcode Formatting Error (2025)

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

Moderate

FDAOct 23, 2025Nationwide• Becton Dickinson & Co.

LEACHOI Bed Rail (Mobility Source) – Entrapment Risk (2025)

This recall involves LEACHOI Bed Rails, ASIN B0BZVCG2R5. The bed rail comes in black/silver and weighs 7.72 pounds. The product measures 15.6 inches by 25.4 inches by 24 inches.

Very High

CPSCOct 23, 2025Nationwide• Mobility Source Medical Technology Co., Ltd, of China

Bromocriptine Capsules (Zydus) - Impurity Deviation (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

Class IIModerate

FDAOct 23, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Ice Cream Factory Graham Pieces – Foreign Material Risk (2025)

Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

Class IIModerate

FDAOct 23, 2025AL, AR, FL +26 more• Ice Cream Factory, LLC

Clomipramine 75mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 25mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Clomipramine 50mg Capsules (Zydus) - Nitrosamine Risk (2025)

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Class IIModerate

FDAOct 22, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc