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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)

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 21320 recalls

Fetal Spiral Electrode (Philips) – Tip Breaking Risk (2022)

Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.

High

FDANov 21, 2022Nationwide• Philips North America Llc

Provido Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

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High

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.

Moderate

FDANov 18, 2022Nationwide• Ventana Medical Systems, Inc.

Natus Cranial Access Kit (Natus) – Recalled Surgical Drapes (2022)

Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

Moderate

FDANov 18, 2022Nationwide• Natus Medical Incorporated

IC Bus EV (IC Bus) – High Voltage Cable Issue (2022)

Navistar, Inc. is recalling certain 2022-2023 IC EV school buses. The high voltage positive cables that connect the battery packs to the manual service disconnects (MSD) may have been mislabeled.

High

NHTSANov 17, 2022Nationwide• IC BUS

VITROS PTH Reagent Pack (Ortho-Clinical) – Result Bias (2022)

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

Moderate

FDANov 17, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Programmable Diagnostic Computer (Siemens) – Software Update (2022)

The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;

Moderate

FDANov 16, 2022Nationwide• Siemens Medical Solutions USA, Inc

B125M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

B105P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

B125P Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

PDS II Suture (Ethicon) – Knot Tensile Weakness (2022)

knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

High

FDANov 16, 2022Nationwide• Ethicon, Inc. Us

B105M Patient Monitor (GE Medical) – CO2 Measurement Error (2022)

Moderate

FDANov 16, 2022Nationwide• GE Medical Systems, LLC

Daytrana (Noven) – Defective Adhesive System (2022)

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

Class IIModerate

FDANov 16, 2022Nationwide• Noven Pharmaceuticals Inc

Hass Avocados (Four Seasons) – Safety Concern (2022)

Sunrise Logistics Inc/ Four Seasons Produce Inc, 400 Wabash , Road Ephrata, PA 17522 has initiated a recall of, PROPAL Hass Avocados, Bag of 6 pieces, Green net with green plastic film, 11 bags per case because they were found to be contaminated with pesticides as per tolerance limit 40CFR 180.275.

Class IIILow

FDANov 15, 2022IN, NJ, PA• Four Seasons Produce Warehouse #2/Sunrise Logistics, Inc

Sodium Sulfacetamide Cleansing Pads (Acella) – Subpotent Drug (2022)

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Power-PRO 2 (Stryker) – Cot Motion Risk (2022)

Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.

Moderate

FDANov 11, 2022Nationwide• Stryker Medical Division of Stryker Corporation

Vivid q Ultrasound (GE Medical) – Battery Failure (2022)

Fire/Burn Risk

Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Moderate

FDANov 10, 2022Nationwide• GE Medical Systems, LLC