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Covidien llc

Active in EUDAMED
Also registered as Covidien

United Statesfrom SRN EUDAMED FDA SRN US-MF-000028763 FEI 1219930

Devices
8,225
Registrations
EUDAMEDFDA
FDA recalls
37344 ongoing
30 open since before 2021

Catalogue8,225

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Company details

EUDAMED SRN
US-MF-000028763
SRN (system / procedure pack)
US-PR-000013794
FDA FEI number
1219930
EUDAMED status
Active
EUDAMED registered name
Covidien llc
Registered address
15, Hampshire Street, MA 02048, Mansfield, United States
Phone
+353 57 96 272 69
PRRC contact
Linda Zhu(public in EUDAMED)
1 more person
  • Deep Pal

EUDAMED certificates3

3 certificates3 valid, 0 expiredMDR 3next expiry 26 Jun 2027

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

FDA recalls373

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 22
  • 2018 25
  • 2019 44
  • 2020 24
  • 2021 26
  • 2022 12
  • 2023 9
  • 2024 8
  • 2025 3
  • 2026 7

193 initiated before 2017

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 Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of Argentina, Australia, Austria, Belgium, Canada, Colombia, Costa Rica, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom.
      Submission number: K183072
    • 23 Apr 2026 Z-2271-2026 Class II Ongoing Temperature probe devices lack FDA clearance.via FDA establishment Covidien Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO,…
      Full distribution text US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
    • 23 Apr 2026 Z-2272-2026 Class II Ongoing Temperature probe devices lack FDA clearance.via FDA establishment Covidien Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO,…
      Full distribution text US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
    • 23 Apr 2026 Z-2273-2026 Class II Ongoing Temperature probe devices lack FDA clearance.via FDA establishment Covidien Distribution: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO,…
      Full distribution text US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IL, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WV.
    • 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 Distribution: U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI,…
      Full distribution text U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Virgin Islands. The countries of Albania, Andorra, Argentina, Australia, Austria, Belgium, Bhutan, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guyana, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lithuania, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Togo, Trinidad And Tobago, Turkey, Uganda, United Arab Emirates, Uruguay.
      Submission number: K843730
    • 15 Apr 2026 Z-2261-2026 Class II Ongoing Due to customer complaint regarding incorrect display box labeling.via FDA establishment Covidien Distribution: Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy,…
      Full distribution text Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.
      Submission number: K812302
    • 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 Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY,…
      Full distribution text Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, and VA. The country of Spain.
      Submission number: K160718

  • 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 Distribution: Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI, NH, ND, NM, ME, CT, DC, WY and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bhutan, Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic Of, Ireland, Isle of Man, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Namibia, Netherlands, New Zealand, North Macedonia, Norway, Oman…
      Submission numbers: K142865, K120773
    • 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 Distribution: Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, Cz…
      Submission number: K111146
    • 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 Distribution: OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia,…
      Full distribution text OUS distribution only to countries of: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
      Submission number: K150844
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 Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia, Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Cameroon, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Rep. Dutch Antilles, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic of Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Ko…
    • 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 Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia, Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Cameroon, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Rep. Dutch Antilles, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic of Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Ko…
    • 9 Jul 2024 Z-2717-2024 Class II Ongoing IFU update to address device's battery handling information.via FDA establishment Covidien Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, US Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Cameroon, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., Dutch Antilles, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French, Guiana French, Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Ke…
    • 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 Distribution: US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT,…
      Full distribution text US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA. OUS: Argentina, Australia, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Montenegro, Namibia, Nepal, New Zealand, Nigeria, Panama, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Viet Nam, South Africa, Austria, Kenya, Latvia, Lebanon, Mongolia, Nicaragua, Thailand, Tunisia, Algeria, Jordan, Libya, Malawi, Qatar, Pakistan, United Arab Emirates, Oman, Peru, Philippines, Bhutan, Iran - Islamic Republic Of, Bolivia, Kuwait, Egypt, Switzerland, Sudan, Norway, Korea - Republic Of, Bahrain, Ethiopia, Paraguay
      Submission number: K070899
    • 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 Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY,…
      Full distribution text Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, United Arab Emirates.
      Submission number: K132337
    • 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 Distribution: US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN,…
      Full distribution text US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.
    • 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 Distribution: US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary…
      Full distribution text US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
      Submission number: K211561
    • 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 Distribution: US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary…
      Full distribution text US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
      Submission number: K182868

  • 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 Distribution: Worldwide distribution - US: Nationwide and surrounding territories. Submission number: K191601
    • 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 Distribution: Unknown
    • 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 Distribution: US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands Submission number: K202874
    • 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 Distribution: US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY…
      Full distribution text US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates
    • 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 Distribution: US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY…
      Full distribution text US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates
    • 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 Distribution: Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland,…
      Full distribution text Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
      Submission number: K181020
    • 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 Distribution: International distribution in the country of Taiwan. Submission number: K191394

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.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

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.