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Showing 261–280 of 11714 results

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IntelliVue Patient Monitor MX800 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP2 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP5 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Patient Monitor MX700 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

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

IntelliVue MP40 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP70 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP30 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP60 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue MP90 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

IntelliVue Multi-Measurement Module X3 (Philips) – monitoring alarm issue (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

Carbocaine 3% (Novocol) - Defective Container (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

IntelliVue MP20 (Philips) – Alarm Failure Risk (2025)

Potential issue where the IntelliVue monitors did not alarm.

High

FDAOct 31, 2025Nationwide• Philips North America Llc

Lidocaine HCI with Epinephrine (Novocol) – cracked cartridges (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

OraVerse Injection (Novocol) - Defective Container (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

Marinara Sauce (First & Last Tavern) – Botulinum Risk (2025)

May be contaminated with Clostridium botulinum

Class IIModerate

FDAOct 31, 2025CT, MA• First & Last Tavern

Organic Moringa Powder (BULK & ORGANIC) – Salmonella Contamination (2025)

Salmonella

Possible Salmonella Richmond

Class IHigh

FDAOct 31, 2025CA, NJ, NY• BULK & ORGANIC LLC

Phytonadione Injectable Emulsion (Cipla) – stability failure (2025)

Failed Stability Specifications: Observed OOS results: eg results for colour index

Class IIModerate

FDAOct 31, 2025Nationwide• Cipla Limited

Wecare Enema (Blossom) – cGMP deviation (2025)

cGMP deviations

Class IIModerate

FDAOct 31, 2025Nationwide• Blossom Pharmaceuticals

Mepivacaine Injection (Novocol) – cracked cartridges (2025)

Defective container: cracked/broken cartridges

Class IIModerate

FDAOct 31, 2025Nationwide• Novocol Pharmaceutical of Canada, Inc.

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