Drugs & medicalClass I

Philips Respironics, Inc. recalls Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home,…

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018…

Read the official notice →
Date
2022-03-30
Country
United States
Brand
Philips Respironics
Product
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home,…
Classification
Class I
Units
Global Distribution. US Nationwide.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Philips Respironics recalls

  1. 2023-04-12
  2. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.…

    A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to…

    FDA · DevicePhilips Respironics, Inc.US Nationwide. France, Reunion.Official notice →
  3. US
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    Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B,…

    The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value…

    FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including Puerto Rico, and countries of…Official notice →
  4. 2023-01-18
  5. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B,…

    The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially…

    FDA · DevicePhilips Respironics, Inc.US Nationwide and Global Distribution to countries of: Australia, Brazil,…Official notice →
  6. 2022-10-12
  7. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Wisp and Wisp Youth Nasal Mask

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

    FDA · DevicePhilips Respironics, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice →
  8. 2022-09-14
  9. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and…

    Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

    FDA · DevicePhilips Respironics, Inc.Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice →
  10. 2022-02-02
  11. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent…

    Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming…

    FDA · DevicePhilips Respironics, Inc.Worldwide Distribution: Distributed to the following US states: AR, CO, FL,…Official notice →
All 22 Philips Respironics recalls →

Other drugs & medical recalls in the United States

  1. 2022-03-30
  2. US
    Drugs & medicalClass III

    Cytocell Ltd. recalls TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome…

    May show unexpected locus specific signals in addition to those at 14q32.

    FDA · DeviceCytocell Ltd.MNOfficial notice →
  3. US
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    Outset Medical, Inc. recalls Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

    Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

    FDA · DeviceOutset Medical, Inc.U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE,…Official notice →
  4. US
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    Biomet, Inc. recalls BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which…

    Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of…

    FDA · DeviceBiomet, Inc.Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA,…Official notice →
  5. US
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    Philips Healthcare recalls Azurion systems with software release R2.0.x

    In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a…

    FDA · DevicePhilips HealthcareUS Nationwide DistributionOfficial notice →
  6. US
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    Fresenius Kabi USA, LLC recalls Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial:…

    Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.

    FDA · DrugFresenius Kabi USA, LLCNationwide USAOfficial notice →
  7. US
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    Tennessee Technical Coatings, Corp. recalls HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings…

    CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.

    FDA · DrugTennessee Technical Coatings, Corp.Distributed in AL, TNOfficial notice →
See all drugs & medical recalls →