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Philips Respironics, Inc.

Philips Respironics, Inc. Recalls

All product recalls associated with Philips Respironics, Inc..

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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 2521–2540 of 21320 recalls

BiPAP V30 Ventilator (Philips) – Therapy Interruption Risk (2024)

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

Very High

FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

POLYSIN Suture (Surgical Specialties) – Needle Curvature Problem (2024)

Complaints have been received with allegations of Incorrect Needle Curvature.

Moderate

FDAMar 26, 2024AZ, CA, IL +6 more• SURGICAL SPECIALTIES

Stealth S8 Software (Medtronic) – Display Information Error (2024)

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

Moderate

FDA

1...125 126127128 129...1066

Page 127 of 1066Next

Mar 26, 2024

Nationwide

• Medtronic Navigation, Inc.

BiPAP A40 Ventilator (Philips) – Therapy Interruption Risk (2024)

Very High

FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

BiPAP A30 Ventilator (Philips) – Therapy Interruption Risk (2024)

Very High

FDAMar 26, 2024Nationwide• Philips Respironics, Inc.

Diltiazem Extended-Release Capsules (Glenmark) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.

Class IIModerate

FDAMar 26, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Rheo Knee XC 3 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Moderate

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Rheo Knee 2 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Moderate

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Rheo Knee XC 5 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Moderate

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Rheo Knee 3 Yr Warranty (Ossur) – Firmware Shutdown Risk (2024)

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Moderate

FDAMar 25, 2024Nationwide• Ossur H F Grjothals 5 Reykjavik Iceland

Methylergonovine Tablets (Amneal) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAMar 25, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Patient Information Center iX UPS (Philips) – Power Supply Failure (2024)

Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition

High

FDAMar 22, 2024Nationwide• Philips North America Llc

Lactated Ringer's Injection (B. Braun) – Potential Sterility Leak (2024)

Lack of assurance of sterility: bags have the potential to leak..

Class IIModerate

FDAMar 22, 2024Nationwide• B. Braun Medical Inc

Root Beer (Pepsico) – mislabeled sugar content (2024)

Product was mislabeled. Can labeled as regular Mug contains Mug Zero Sugar

Class IIILow

FDAMar 22, 2024AR, LA, MS +3 more• Pepsico Inc.

Fentanyl Citrate (IntegraDose) – Sterility Risk: Leaking (2024)

Lack of Assurance of Sterility: leaking bags

Class IIModerate

FDAMar 22, 2024Nationwide• IntegraDose Compounding Services LLC

Expo 5F Angiographic Catheters (Boston Scientific) – Guidewire Advancement Issue (2024)

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Moderate

FDAMar 21, 2024Nationwide• Boston Scientific Corporation

Artis Fluoroscopic X-Ray System (Siemens) – Cooling Circuit Failure (2024)

Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

Moderate

FDAMar 21, 2024Nationwide• Siemens Medical Solutions USA, Inc