Skip to content

Covidien llc

United States US-MF-000017721 Last updated 23 Oct 2026

Devices
8,225
Registries
EUDAMEDFDA
FDA recalls
37374 ongoing

Catalogue8,225

Page 1 of 40

Showing 1-50 of 8,225

EUDAMED certificates3

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (3)

Notified body 2797 2 certificates

  • MDR 728352 Reissued

    Quality management system EU MDR

    Issued
    27 Aug 2026
    Expires
    31 Aug 2031
    Valid from
    31 Aug 2026
  • MDR 724712 Supplemented

    Quality management system EU MDR

    Issued
    25 Sep 2026
    Expires
    11 Aug 2031
    Reason
    Other

DNV Product Assurance AS 2460 1 certificate

  • 10000481938-PA-NoMA-DNK Amended

    Quality management system EU MDR

    Issued
    16 Jul 2026
    Expires
    26 Jun 2027
    Reason
    Mnf data change

Related companies

Authorised representatives

Notified bodies

FDA recalls373

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 373 recalls.

  • 2026

    • 13 May 2026 Z-2950-2026 Class II Ongoing Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.via FDA establishment Covidien
    • 23 Apr 2026 Z-2271-2026 Class II Ongoing Temperature probe devices lack FDA clearance.via FDA establishment Covidien
    • 23 Apr 2026 Z-2272-2026 Class II Ongoing Temperature probe devices lack FDA clearance.via FDA establishment Covidien
    • 23 Apr 2026 Z-2273-2026 Class II Ongoing Temperature probe devices lack FDA clearance.via FDA establishment Covidien
    • 23 Apr 2026 Z-2653-2026 Class II Ongoing Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.via FDA establishment Covidien
    • 15 Apr 2026 Z-2261-2026 Class II Ongoing Due to customer complaint regarding incorrect display box labeling.via FDA establishment Covidien
    • 30 Jan 2026 Z-1557-2026 Class II Ongoing 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.via FDA establishment Covidien

  • 2025

    • 23 Jun 2025 Z-2151-2025 Class II Ongoing 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 Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional settingvia FDA establishment Covidien
    • 21 May 2025 Z-1915-2025 Class I Ongoing 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, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.via FDA establishment Covidien
    • 26 Feb 2025 Z-1390-2025 Class I Ongoing 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, respiratory tract infection, bronchospasm, a delay to treatment and/or death.via FDA establishment Covidien
Show the 25 most recent of 373 recalls

  • 2024

    • 9 Jul 2024 Z-2636-2024 Class I Ongoing Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.via FDA establishment Covidien
    • 9 Jul 2024 Z-2637-2024 Class I Ongoing Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.via FDA establishment Covidien
    • 9 Jul 2024 Z-2717-2024 Class II Ongoing IFU update to address device's battery handling information.via FDA establishment Covidien
    • 24 Jun 2024 Z-2446-2024 Class I Ongoing Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathwayvia FDA establishment Covidien
    • 25 Apr 2024 Z-2038-2024 Class II Ongoing Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.via FDA establishment Covidien
    • 21 Feb 2024 Z-1330-2024 Class II Ongoing Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.via FDA establishment Covidien
    • 9 Jan 2024 Z-1731-2024 Class II Ongoing manufacturing defects to sensor cable connectors may result in error codes or non-functioning channelvia FDA establishment Covidien
    • 9 Jan 2024 Z-1732-2024 Class II Ongoing manufacturing defects to sensor cable connectors may result in error codes or non-functioning channelvia FDA establishment Covidien

  • 2023

    • 16 Nov 2023 Z-0631-2024 Class II Ongoing Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperablevia FDA establishment Covidien
    • 28 Sep 2023 Z-0144-2024 Class I Ongoing Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.via FDA establishment Covidien
    • 22 Aug 2023 Z-2651-2023 Class II Ongoing Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.via FDA establishment Covidien
    • 10 Aug 2023 Z-0168-2024 Class II Ongoing Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.via FDA establishment Covidien
    • 10 Aug 2023 Z-0169-2024 Class II Ongoing Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.via FDA establishment Covidien
    • 2 Jun 2023 Z-2282-2023 Class II Ongoing Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.via FDA establishment Covidien
    • 22 May 2023 Z-2008-2023 Class II Ongoing Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.via FDA establishment Covidien

FDA establishments3

Registered with the FDA under this company group, matched by name.

  • Covidien TIJUANA, B.C. Mexico · MX FEI 3002807391
  • Covidien - Galway(County) · IE FEI 3002807850
  • Covidien - Santo Domingo · DO FEI 3003495548

What Covidien llc makes

Covidien LLC manufactures reusable device sterilization and disinfection containers, single-use basic endotracheal tubes, and secretion suction kits. Their portfolio includes sterile surgical procedure packs for gynecological, bariatric, appendectomy, colorectal, and thoracic surgeries, as well as silicone Foley catheters and breathing circuits with reservoir bags. Electrostatic filters are also part of their product line.

The company’s devices are classified under EU regulations as Class I, Class IIa, Class IIb, and Class III, with listings maintained in the EUDAQMED database. Covidien LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Covidien LLC primarily manufacture?

Covidien LLC specializes in reusable device sterilization and disinfection containers, single-use basic endotracheal tubes, and secretion suction kits. Their product portfolio also includes sterile surgical procedure packs for various specialties like gynecology, bariatric, appendectomy, colorectal, and thoracic surgeries, along with silicone Foley catheters and breathing circuits with reservoir bags. These devices are designed for use in surgical, critical care, and procedural settings.

Where is Covidien LLC based, and what does this mean for its regulatory oversight?

Covidien LLC is based in the United States. Since the company operates in the EU market, its devices are subject to EU regulatory requirements, including classification under EU Medical Device Regulations (MDR) or Medical Device Directives (MDD). The company maintains listings for its devices in the EUDAQMED database, which is the official EU registry for medical devices.

Which EU regulatory registries list Covidien LLC’s medical devices?

Covidien LLC’s medical devices are listed in the EUDAQMED database, which is the official EU registry for tracking medical devices authorized under EU regulations. This registry ensures transparency and compliance with the European Union’s medical device framework, allowing healthcare professionals and regulators to verify device details and regulatory status.

How are Covidien LLC’s devices classified under EU regulations, and why does this matter?

Covidien LLC’s devices fall into four EU classification categories: Class I (low-risk, general controls), Class IIa (moderate risk, requiring additional measures), Class IIb (higher risk, stringent controls), and Class III (highest risk, such as life-supporting devices, demanding rigorous pre-market approval). Classification determines the regulatory pathway, including documentation requirements, clinical evaluations, and post-market surveillance obligations, ensuring appropriate oversight based on device risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United States
Address
15, Hampshire Street, Mansfield, United States
Website
medtronic.com
EUDAMED SRN
US-MF-000017721
FDA FEI number
1219930