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Philips Ultrasound, LLC

Philips Ultrasound, LLC Recalls

All product recalls associated with Philips Ultrasound, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

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 1–20 of 45 recalls

Lumify Diagnostic Ultrasound System (Philips) – iOS Compatibility Issue (2025)

Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

Moderate

FDAOct 31, 2025Nationwide• Philips Ultrasound, LLC

Phasor Drill (Phasor Health) – battery orientation risk (2025)

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

FDAMar 21, 2025AZ, AR, CA +25 more• Phasor Health, LLC

Strawberry Rhubarb Bakewell Tart (New Seasons Market) – undeclared almond (2024)

Undeclared Allergen

Undeclared almond.

Class IHigh

FDA

12 3

Page 1 of 3Next

Jun 3, 2024

IN, OR, WA

• New Seasons Market LLC

DiaSorin Molecular LLC: Simplexa Direct Amplification Disc Kit, Rx Only, IVD The...

There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.

FDAJun 14, 2023Nationwide• DiaSorin Molecular LLC

ASO LLC: WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK...

The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling.

FDAMar 23, 2023Nationwide• ASO LLC

Sofrito Marinating Sauce (20-100 Seasoning) - Improper Storage (2023)

Product was not stored refrigerated.

Class IIModerate

FDAMar 9, 2023Nationwide• 20-100 Delicious Seasoning LLC

DiaSorin Molecular LLC: Simplexa COVID-19 Direct, REF: MOL4150; including Reactio...

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

FDAJan 30, 2023Nationwide• DiaSorin Molecular LLC

DiaSorin Molecular LLC: Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; inclu...

Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.

FDAJan 30, 2023Nationwide• DiaSorin Molecular LLC

Philips Ultrasound, LLC: Philips EPIQ Ultrasound Systems (various models) used in...

Retroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer.

FDAJul 14, 2022Nationwide• Philips Ultrasound, LLC

ASO LLC: (1) CVS Health Sterile Surgical Pads, Cushion Comfort, pa...

The product falls apart during handling after removal from its primary packaging.

FDAJun 22, 2022Nationwide• ASO LLC

Valencia Almonds (New Seasons) – Peanut Contamination (2022)

Undeclared Nuts

Undeclared peanut due to raw material contamination.

Class IHigh

FDAMay 4, 2022IN, OR, WA• New Seasons Market LLC

Truffle Valencia Almonds (New Seasons Market) – Foreign Materials (2022)

Potential foreign materials contamination.

Class IIModerate

FDAApr 29, 2022IN, OR, WA• New Seasons Market LLC

ASO LLC: First Aid Kits containing acetaminophen under brand names...

Kits contained recalled acetaminophen.

FDAMar 2, 2022Nationwide• ASO LLC

DiaSorin Molecular LLC: Simplexa Direct Amplification Disc Kit, Product Kit Code ...

A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned.

FDANov 19, 2021AZ, CA, CO +38 more• DiaSorin Molecular LLC

DiaSorin Molecular LLC: SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD...

Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.

FDASep 23, 2021Nationwide• DiaSorin Molecular LLC

DiaSorin Molecular LLC: MOL3655 Simplexa VZV Swab Direct - Product Usage: is inte...

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

FDAMay 12, 2020Nationwide• DiaSorin Molecular LLC

DiaSorin Molecular LLC: MOL3650 Simplexa VZV Direct - Product Usage: is intended ...

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

FDAMay 12, 2020Nationwide• DiaSorin Molecular LLC

DiaSorin Molecular LLC: MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutan...

Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

FDAMay 12, 2020Nationwide• DiaSorin Molecular LLC

Chili Powder (K F K Seasonings) - Undeclared Allergens (2020)

Undeclared Nuts

Undeclared tree nuts and Crustacea.

Class IHigh

FDAMay 8, 2020IN, OR, UT• K F K Seasonings Llc

Organic Ground Oregano (K F K Seasonings) - Undeclared Allergens (2020)

Undeclared Nuts

Undeclared tree nuts and Crustacea.

Class IHigh

FDAMay 8, 2020IN, OR, UT• K F K Seasonings Llc