Skip to content

Covidien llc

United States Last updated 25 Oct 2026

Devices
8,225
Registries
EUDAMEDFDA
FDA recalls
37374 ongoing

Catalogue8,225

Page 34 of 40

Showing 1,651-1,700 of 8,225

EUDAMED certificates3

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

Device pages show only the recalls that name the device or its 510(k)/PMA.

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

How many devices does Covidien llc have in the registry?

The registry currently lists 8225 devices for Covidien llc. Devices recorded under merged duplicate company entries are counted once.

Are there FDA recall records for Covidien llc?

FDA recall records list 373 recalls initiated by Covidien llc, the most recent initiated on 2026-05-13. 74 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Covidien llc?

EUDAMED lists 3 certificates for Covidien llc (quality management system) under MDR. The most recent was issued on 2026-09-25.

Which FDA establishments are linked to Covidien llc?

3 FDA establishments are linked to Covidien llc in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
15 , Hampshire Street, Mansfield, United States
Phone
+353 57 96 272 69
PRRC contact
Linda Zhu
EUDAMED SRN
US-MF-000028763
FDA FEI number
1219930