Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Philips North America Llc

Philips North America Llc Recalls

All product recalls associated with Philips North America Llc.

Get alerts for this brand

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 801–820 of 21319 recalls

Spectral CT X-ray System (Philips) – Motion Safety Issue (2025)

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

Very High

FDAMay 29, 2025AZ, CA, CO +16 more• Philips North America Llc

Achieva XR (Philips) – Heat Source Risk (2025)

Fire/Burn Risk

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

Very High

FDAMay 29, 2025Nationwide• Philips North America

Levothyroxine Sodium Tablets (Macleods) – Foreign Substance (2025)

Presence of a foreign substance: black hair found embedded in tablet.

1...39 404142 43...1066

Page 41 of 1066Next

Class IIILow

FDAMay 29, 2025Nationwide• Macleods Pharmaceuticals Ltd

LIFEPEARL Drug Microspheres (MicroVention) – Diameter Specification Issue (2025)

Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.

Moderate

FDAMay 29, 2025GA• MICROVENTION INC.

Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.

Class IIModerate

FDAMay 28, 2025AL, FL, GA +3 more• Camerican International Inc

Azurion R1.x and R2.x Systems (Philips) – Communication Software Issue (2025)

Laceration Risk

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

Very High

FDAMay 28, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

KWIK-STICK Control Kit (Microbiologics) – Incorrect Microorganism (2025)

Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.

Moderate

FDAMay 27, 2025Nationwide• Microbiologics Inc

Transamerican Mutant X-AT Predator Tire (Transamerican) – Sidewall Defect (2025)

Sailun Tire Americas, Inc. (Sailun) is recalling certain Transamerican New Mutant X-AT Predator tires, size 265/70R17 115S. The sidewall may have a puncture and leak air. As such, these tires fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 139, "New Pneumatic Radial Tires for Light Vehicles."

Moderate

NHTSAMay 27, 2025Nationwide• TRANSAMERICAN

Nootri Toto (East Africa Boutique) – Insanitary Conditions (2025)

Products held under insanitary conditions

Class IIModerate

FDAMay 27, 2025IN, KY, MO +1 more• East Africa Boutique, LLC.

Sodium Chloride Injection (Fresenius) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 27, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

O-arm O2 Imaging System (Medtronic) – Gantry Support Damage (2025)

A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

Moderate

FDAMay 27, 2025Nationwide• Medtronic Navigation, Inc.-Boxborough

Super Cereal Plus (East Africa Boutique) – Insanitary Conditions (2025)

Products held under insanitary conditions

Class IIModerate

FDAMay 27, 2025IN, KY, MO +1 more• East Africa Boutique, LLC.

Micro DOT Blister Helmet (Micro DOT) – Penetration Protection Issue (2025)

Micro DOT Helmet Co. (Micro DOT) is recalling certain Blister and Twister original helmets, sizes XXS - XXL. The helmets may lack proper penetration protection. As such, these helmets fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 218, "Motorcycle Helmets."

Moderate

NHTSAMay 26, 2025Nationwide• MICRO DOT

Salmon Portions (Santa Monica Seafood) – Undeclared Soy (2025)

Atlantic Salmon Portions with Seafood Stuffing was incorrectly labeled and does not declare allergen ingredient (SOY)

Class IHigh

FDAMay 24, 2025Nationwide• Santa Monica Seafood Company

SIGNA PET/MR (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

Moderate

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC