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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

593

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 1381–1400 of 10391 recalls

Brilliance CT Big Bore Oncology (Philips) – Contouring Shift Risk (2023)

For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

FDAOct 9, 2023Nationwide• Philips North America Llc

ORION System (LEONI) – Unintended Movement Risk (2023)

Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.

FDAOct 6, 2023Nationwide• LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France

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Favorite Day Demi French Bread (Rise Baking) – Foreign material (2023)

Foreign Material (plastic).

Class IIModerate

FDAOct 5, 2023CA, IA• Rise Baking Company, LLC dba The New French Bakery Inc.

Integris-Allura IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

FDAOct 4, 2023Nationwide• Philips North America

BV Endura Surgery Systems (Philips) – Puerto Rico Delivery Issue (2023)

FDAOct 4, 2023Nationwide• Philips North America

Hillrom Progressa+ Bed (Baxter) – Static Electricity Risk (2023)

Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.

FDAOct 4, 2023Nationwide• Baxter Healthcare Corporation

Blood Uric Acid Monitoring System (Visgeneer) – Unapproved Distribution (2023)

Due to products distributed without premarket clearance or approvals.

FDAOct 4, 2023Nationwide• Visgeneer, Inc. No. 335 Zhong Hua Rd., Sec. 6 Xiangshan Dist. Hsinchu City Taiwan

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

Class IIILow

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

Class IIILow

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Oxytocin IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

Class IIILow

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

DRX-Revolution Mobile X-Ray (Carestream) – Generator Failure Risk (2023)

Fire/Burn Risk

There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.

FDAOct 2, 2023Nationwide• Carestream Health, Inc.

DRX Revolution X-Ray System (Carestream) – Electrical Component Failure (2023)

Unexpected failure of electrical components within the CPI generator.

FDAOct 2, 2023Nationwide• Carestream Health, Inc.

IRON Assay (Sentinel) – High Recovery Issue (2023)

A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

FDASep 29, 2023Nationwide• Sentinel CH SpA Via Robert Koch

Alinity c Iron Reagent (Sentinel) – High Recovery Issue (2023)

FDASep 29, 2023Nationwide• Sentinel CH SpA Via Robert Koch

Zevo Flying Insect Killer (Procter & Gamble) – Injury risk (2023)

Laceration Risk

This recall involves Zevo Fly, Gnat and Fruit Fly Flying Insect Killer3 Value Packs. The twin pack aerosol containers are shrink-wrapped together with a white and purple label. The batch code 3045D185EW3 is printed on the bottom of the aerosol containers or on the shrink-wrap. "Zevo Insect Killer" and "Fly, Gnat & Fruit Fly" and "Kills on Contact" are printed on the shrink-wrap.

CPSCSep 28, 2023Nationwide• The Procter & Gamble Company, of Cincinnati, Ohio

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

Stay Informed

Philips North America Llc Recalls

Recall Summary

Brilliance CT Big Bore Oncology (Philips) – Contouring Shift Risk (2023)

ORION System (LEONI) – Unintended Movement Risk (2023)

Favorite Day Demi French Bread (Rise Baking) – Foreign material (2023)

Integris-Allura IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

BV Endura Surgery Systems (Philips) – Puerto Rico Delivery Issue (2023)

Hillrom Progressa+ Bed (Baxter) – Static Electricity Risk (2023)

Blood Uric Acid Monitoring System (Visgeneer) – Unapproved Distribution (2023)

Allura Xper IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

Azurion IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

Veradius Unity C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Zenition Mobile Surgery C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Oxytocin IV Bag (Denver Solutions) – Labeling Issue (2023)

DRX-Revolution Mobile X-Ray (Carestream) – Generator Failure Risk (2023)

DRX Revolution X-Ray System (Carestream) – Electrical Component Failure (2023)

IRON Assay (Sentinel) – High Recovery Issue (2023)

Alinity c Iron Reagent (Sentinel) – High Recovery Issue (2023)

Zevo Flying Insect Killer (Procter & Gamble) – Injury risk (2023)

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)