Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through…
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Read the official notice →- Date
- 2024-11-20
- Country
- United States
- Brand
- Philips Respironics
- Product
- Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult…
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2025-11-19
USPhilips Respironics, Inc. recalls SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini:…
Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while…
FDA · DevicePhilips Respironics, Inc.US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country…Official notice →- 2025-08-20
- US
Philips Respironics, Inc. recalls DreamStation Auto BiPAP. Non-Continuous Ventilator.
Devices may possess a programming error resulting in an incorrect device configuration.
FDA · DevicePhilips Respironics, Inc.Worldwide - US Nationwide in the states of AL, CA, CO, FL, GA, IN, LA, MD, NE,…Official notice → - 2025-07-09
- US
Philips Respironics, Inc. recalls BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP…
This device does not indicate for use in patients with respiratory failure.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS…Official notice → - 2024-09-11
- US
Philips Respironics, Inc. recalls Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo,…
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU,…Official notice → - 2024-05-29
- US
Philips Respironics, Inc. recalls OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127…
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or…
FDA · DevicePhilips Respironics, Inc.US Nationwide distribution and OUS International distribution to Canada.Official notice → - US
Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator, Part Number 1111178
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…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium,…Official notice →
Other drugs & medical recalls in the United States
- 2024-11-20
- US
Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health…
- US
Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA · DeviceDraeger Medical, Inc.US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY,…Official notice → - US
Boston Scientific Corporation recalls Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
- US
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet…
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the US.Official notice → - US
Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.