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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 4981–5000 of 21320 recalls

Amara View Mask (Philips) – Magnetic Component Warning (2022)

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

Moderate

FDASep 6, 2022Nationwide• Philips Respironics, Inc.

Clip COVID Rapid Test (Clip Health) – Shelf Life Extension (2022)

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

Moderate

FDASep 2, 2022Nationwide• LUMINOSTICS, INC dba CLIP HEALTH

Veritas Advanced Infusion Packs (Johnson & Johnson) – Broken Irrigation Luer (2022)

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

High

FDA

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Sep 1, 2022

AL, AZ, AR +22 more

• Johnson & Johnson Surgical Vision, Inc.

Introcan Safety FEP (B Braun Medical) – Catheter Hub Leakage (2022)

Potential for leakage at the catheter hub.

Moderate

FDASep 1, 2022AZ, CA, FL +12 more• B Braun Medical Inc

Surgical Gown (Texas Medical) – Hydrostatic Pressure Failure (2022)

Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.

High

FDASep 1, 2022Nationwide• Texas Medical Technology Inc.

Rover Mobile X-Ray System (Micro-X) – DAP Meter Calibration Error (2022)

Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

High

FDAAug 31, 2022Nationwide• Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia

BN ProSpec System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

Moderate

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

Pinnacle3 Radiation Planning System (Philips) – Dose Export Error (2022)

When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.

High

FDAAug 30, 2022CA, FL, GA +18 more• Philips Medical Systems (Cleveland) Inc

BN II System Antiserum (Siemens) – Reagent Performance Issue (2022)

N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

Moderate

FDAAug 30, 2022Nationwide• SIEMENS HEALTHCARE DIAGNOSTICS INC

Solus Laryngeal Mask Airway (Intersurgical) – Incorrect Size Marking (2022)

Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size identifier, patient weight and maximum inflation volume on the airway tube and the marking #4 on the inflation line pilot balloon) may pose health risk to the patient

High

FDAAug 29, 2022OH, TN, TX• Intersurgical Inc

ADHD Medication (Teva) – Strength Labeling Error (2022)

Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

Class IIModerate

FDAAug 29, 2022Nationwide• Teva Pharmaceuticals USA Inc

Power Knee (Ossur) – Battery Dislodge Risk (2022)

Battery may dislodge from the Power Knee

High

FDAAug 29, 2022Nationwide• Ossur Americas