Covidien recalls Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.…
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation,…
Read the official notice →- Date
- 2025-06-18
- Country
- United States
- Brand
- Covidien
- Product
- Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.…
- Classification
- Class I
- Units
- Worldwide - US Nationwide distribution including in the states of MA, CT, KS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Covidien recalls
- 2026-03-18
US
Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI…
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
FDA · DeviceCovidien LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL,…Official notice →- 2025-11-19
US
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice →- 2025-07-30
US
Covidien recalls Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,…
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of MS, TX, FL,…Official notice →- 2025-04-02
US
Covidien recalls Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration,…
FDA · DeviceCovidienOUS distribution only to countries of: France, Germany, Ireland, Italy,…Official notice →- 2024-11-06
US
Covidien LP recalls Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm…
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
FDA · DeviceCovidien LPWorldwide Distribution: US (Nationwide) and OUS (foreign) to countries of:…Official notice →- 2024-08-28
US
Covidien recalls Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
IFU update to address device's battery handling information.
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2025-06-18
US
Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, CL, DE,…Official notice →US
Cardinal Health 200, LLC recalls SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
FDA · DeviceCardinal Health 200, LLCDomestic US distribution to AK, CA, FL, MA, TX. International distribution to…Official notice →US
American Contract Systems, Inc. recalls LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model:…
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the state of CO.Official notice →US
Stryker GmbH recalls Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
FDA · DeviceStryker GmbHWorldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the…Official notice →US
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular…
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
FDA · DeviceFresenius Kabi USA, LLCUS distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX,…Official notice →US
Zyno Medical LLC recalls Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Unreleased software versions were installed on distributed devices without verification or validation.