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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)

143

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 4761–4780 of 37665 recalls

Spectral CT 7500 (Philips) – Software Functionality (2023)

Multiple software issues that affect device functionality.

Moderate

FDANov 30, 2023Nationwide• Philips North America Llc

BrightView Gamma Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

High

FDANov 30, 2023Nationwide• Philips North America

BrightView X Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

1...237 238239240 241...1884

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High

FDANov 30, 2023Nationwide• Philips North America

RX Series Copper Assay (Randox) – Carryover Testing (2023)

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Moderate

FDANov 29, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Cardiac Procedural Kits (American Contract) – Sterilization Issue (2023)

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Moderate

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Anesthesia Procedural Kits (American Contract) – Sterilization Issue (2023)

Moderate

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Magnum XXL Capsules (Meta Herbal) – Undeclared Sildenafil (2023)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Class IHigh

FDANov 29, 2023Nationwide• Meta Herbal

Medline Gown Poly Breath Sleeves (Medline) – Incorrect Sleeve (2023)

Surgical gowns were manufactured with the wrong sleeve.

Moderate

FDANov 29, 2023MD, OH, TN +2 more• MEDLINE INDUSTRIES, LP Northfield

Cortera Spinal Fixation System (XTANT) – Screw Shank Incorrect (2023)

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

Low

FDANov 28, 2023IN, MI• XTANT Medical Holdings, Inc

Patient Information Center (Philips) – Push Notification Failure (2023)

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

Moderate

FDANov 28, 2023Nationwide• Philips North America

VADER Pedicle System (Icotec) – Loose Nut Screws (2023)

icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.

Moderate

FDANov 28, 2023AZ, CA, CO +7 more• Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland

EDS 3 CSF Drainage System (Natus) – Sterility Concern (2023)

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Moderate

FDANov 28, 2023Nationwide• Natus Medical Incorporated

Volar Bearing Plate (TriMed) – Bearing Displacement Risk (2023)

Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

Moderate

FDANov 28, 2023AL, CA, FL +2 more• TriMed Inc.

Scoot Control R-net (mo-Vis) – Throttle Lever Stuck (2023)

In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.

Moderate

FDANov 28, 2023TN, TX• mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium

External Drainage Collection Bag (Natus) – Sterility Concern (2023)

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Moderate

FDANov 28, 2023Nationwide• Natus Medical Incorporated

CareEvent Monitor (Philips) – Push Notification Failure (2023)

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

Moderate

FDANov 28, 2023Nationwide• Philips North America

Tank Hose Assembly (AtriCure) – Incorrect Supplier (2023)

AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

Moderate

FDANov 28, 2023Nationwide• AtriCure, Inc.

Cryo Module Accessories (AtriCure) – Incorrect Supplier (2023)

Moderate

FDANov 28, 2023Nationwide• AtriCure, Inc.

Captus 4000e Thyroid Uptake System – Spring Arm Failure (2023)

Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

Moderate

FDANov 27, 2023Nationwide• Mirion Technologies (Capintec), Inc.

Whole Cantaloupe (Pacific Trellis) – Salmonella (2023)

Salmonella

Class IHigh

FDANov 24, 2023CA, IL, OK +2 more• PACIFIC TRELLIS FRUIT, LLC