Skip to content

Covidien LP

Country not established

Devices
9,818
FDA recalls
19998 ongoing since 2021 (107 open in total)
9 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue9,818

Newest first, rows 1-50 of 9,818

Search and filter all 9,818 devices
Skip device list

  • LigaSure MRASILF19

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110860

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110865

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110870

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110885

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110875

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110880

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Shiley 110890

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Touch Surgery MDS30028

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Vital Sync VITALSYNCSW03 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Touch Surgery MDS30001

    Listed Registry: GUDID Class:I

  • Trexon CY904P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon CY954P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon CY811P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon CY843P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon CY953P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon CY883P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon GY323P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon GY123P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY823P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon GY122P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY923P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon GY322P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5628P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5638P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5679GP

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY632P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY693P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY822P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY922P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon UY204P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon GY121P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon GY321P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5627P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5678P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5637P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5679P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY791P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5690P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY633P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY691P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon UY203P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon UY214P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon UY202P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Trexon SY5687P

    Active Regimes: 510(k) Registry: GUDID Class:II

  • LigaSure MRASILF19

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • SharkCore L-19-05

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Tri-Staple 2.0 SIGCIR21XT

    Listed Registry: GUDID Class:II

  • Tri-Staple 2.0 SIGCIR25XT

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Tri-Staple 2.0 SIGCIR21MTORVIL

    Active Regimes: 510(k) Registry: GUDID Class:II

Rows 1-50 of 9,818

Showing 1-50 of 9,818

Company details

DUNS number
058614483
Phone
+1(508)261-8000

FDA recalls199

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 9
  • 2021 26
  • 2022 15
  • 2023 38
  • 2024 14
  • 2025 2
  • 2026 6

88 initiated before 2017

Showing the 10 most recent of 199 recalls.

  • 2026

    • 24 Jun 2026 Z-2918-2026 Class II Ongoing Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China,…
      Full distribution text US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
      Submission number: K100257
    • 24 Jun 2026 Z-2919-2026 Class II Ongoing Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China,…
      Full distribution text US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
      Submission numbers: K091087, K093408
    • 24 Jun 2026 Z-2920-2026 Class II Ongoing Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China,…
      Full distribution text US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
      Submission number: K981582
    • 24 Jun 2026 Z-2921-2026 Class II Ongoing Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China,…
      Full distribution text US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
    • 24 Jun 2026 Z-2922-2026 Class II Ongoing Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. Distribution: US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China,…
      Full distribution text US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
      Submission number: K050947
    • 15 Apr 2026 Z-2281-2026 Class II Ongoing The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. Distribution: Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy; Submission number: K934738

  • 2025

    • 25 Sep 2025 Z-0485-2026 Class II Ongoing 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. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
      Submission numbers: K191070, K222641
    • 25 Sep 2025 Z-0486-2026 Class II Ongoing 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. Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Chile, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kuwait, Malaysia, Netherlands, Poland, Portugal, Romania, Saudi Arabia, Slovakia, Spain, United Kingdom.
      Submission number: K191070

  • 2024

    • 19 Sep 2024 Z-0257-2025 Class II Ongoing Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China,…
      Full distribution text Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Canada, Canary Islands, China, France, French Guiana, Germany, Greece, Guadeloupe, India, Ireland, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Spain and Turkey.
      Submission number: K163231
    • 15 Apr 2024 Z-1891-2024 Class II Ongoing Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi…
      Full distribution text Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
      Submission number: K173270
Show the 25 most recent of 199 recalls

  • 2024

    • 15 Mar 2024 Z-1634-2024 Class II Ongoing Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.
      Submission number: K123196
    • 15 Mar 2024 Z-1635-2024 Class II Ongoing Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Denmark, Faroe Islands, France, Germany, Greece, Iceland, Ireland, Italy, Mayotte, Norway, Poland, Reunion, South Africa, Spain, Sweden, United Kingdom.
      Submission number: K123196
    • 28 Feb 2024 Z-1465-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 28 Feb 2024 Z-1466-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 28 Feb 2024 Z-1467-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 28 Feb 2024 Z-1468-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 28 Feb 2024 Z-1469-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 28 Feb 2024 Z-1470-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 28 Feb 2024 Z-1471-2024 Class II Ongoing The potential for trocar seal disengagement when using mesh products incorrectly with the device. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
      Submission number: K924011
    • 14 Feb 2024 Z-1457-2024 Class II Ongoing Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System. Distribution: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. Submission number: K191070
    • 14 Feb 2024 Z-1458-2024 Class II Ongoing Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System. Distribution: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan. Submission number: K191070
    • 25 Jan 2024 Z-1697-2024 Class II Ongoing One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, blood loss, bleeding, tissue breakdown, peritonitis, unspecified infection, vision loss (when used in ophthalmic application), and/or prolonged surgery. Distribution: International distribution in the countries of Portugal and Italy. Submission number: K981128

  • 2023

    • 21 Dec 2023 Z-0844-2024 Class II Ongoing Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level. Distribution: Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS,…
      Full distribution text Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
      Submission number: K981582
    • 21 Dec 2023 Z-0845-2024 Class II Ongoing Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level. Distribution: Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS,…
      Full distribution text Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
      Submission number: K981128
    • 16 Nov 2023 Z-0986-2024 Class II Ongoing Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility Distribution: US Nationwide distribution in the states of CA, CO, FL, IL, TX. Submission number: K090470

Frequently asked questions

How many devices does Covidien LP have in the registry?

The registry currently lists 9818 devices for Covidien LP. Devices recorded under merged duplicate company entries are counted once.

Which registries list Covidien LP's devices?

Among its 50 most recently registered devices, Covidien LP has devices listed in EUDAMED (2 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Covidien LP's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Covidien LP's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Covidien LP?

FDA recall records list 199 recalls initiated by Covidien LP, the most recent initiated on 24 Jun 2026. 107 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 are the newest devices from Covidien LP in the registry?

The most recently registered devices listed for Covidien LP include LigaSure MRASILF19, Shiley 110860, Shiley 110865 and Shiley 110870.

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