The Recall Desk

Manufacturer

Covidien, LLC

341 recalls in our database name Covidien, LLC as the manufacturing or recalling firm.

What the numbers show

Total
341
Critical
4
Severe
111
Most recent
2026-08-26

Of the 341 recalls from Covidien, LLC we have scored against our rubric, 4 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 111 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 341

  • SevereFDA (Devices)·Z-1836-2019·2019-06-26

    Signia Tri-Staple Surgical Device Recalled Due to Missing Pin Components

    The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2019·2019-06-26

    Covidien EGIA 45 Articulating Medical Stapler Recall for Missing Pins

    FDA is recalling 3.1 million EGIA 45 staplers due to missing pins that may cause incomplete stapling and serious surgical complications.

    Product
    EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1825-2019·2019-06-26

    FDA Recalls Covidien EGIA 30 Articulating Medical Devices

    The FDA is recalling 3,113,280 units of the EGIA 30 Articulating Medical device due to missing pin components that may cause incomplete staple formation and serious surgical complications.

    Product
    EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1831-2019·2019-06-26

    FDA Recalls 3.1 Million Covidien Surgical Staplers Due to Missing Pins

    The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    EGIA45 CT AR MD THK REL, EGIA45CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1830-2019·2019-06-26

    Covidien EGIA 60 Curved Tip Surgical Stapler Recall for Missing Pins

    FDA is recalling 3,113,280 units of the EGIA 60 Curved Tip Art Med Thick Sulu surgical stapler because missing pin components may cause incomplete staple formation and serious medical complications.

    Product
    EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2019·2019-06-26

    Recall of Signia Tri-Staple 2.0 Surgical Reloads Due to Missing Pins

    Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, potentially leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1833-2019·2019-06-26

    Recall of Signia Tri-Staple 2.0 Reloads Due to Missing Pin Components

    Covidien LLC is recalling Signia Tri-Staple 2.0 reloads because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1829-2019·2019-06-26

    Covidien EGIA 60 Articulating Medical Stapler Recall for Missing Pins

    FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.

    Product
    EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1828-2019·2019-06-26

    FDA Recalls Covidien EGIA 60 Articulating Extra Thick Sulu Devices

    The FDA is recalling 3,113,280 units of the EGIA 60 Articulating Extra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious surgical complications.

    Product
    EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1827-2019·2019-06-26

    FDA Recalls 3.1 Million Covidien EGIA 45 Articulating Xtra Thick Sulu Devices

    The FDA is recalling 3,113,280 units of the EGIA 45 Articulating Xtra Thick Sulu device due to a missing pin component that may cause incomplete staple formation and serious medical complications.

    Product
    EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2019·2019-06-26

    FDA Recalls Signia Tri-Staple 2.0 Devices Due to Missing Pin Components

    The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.

    Product
    SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2019·2019-05-01

    Covidien Endo Clinch II Auto Suture Grasper Recalled for Sterilization Issues

    COVIDIEN LLC is recalling 7,248 units of the Endo Clinch II Auto Suture Grasper because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1212-2019·2019-05-01

    Covidien Endo Grasp Auto Suture Grasper Recalled for Sterilization Labeling Error

    COVIDIEN LLC is recalling 240 units of the Endo Grasp Auto Suture Grasper 5mm because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a variety of gynecologic, general, urologic, thoracic and endoscopic procedures for temporary grasping/clamping of tissue and small tubula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1213-2019·2019-05-01

    Covidien Procedure Kits Recalled for Sterilization Labeling Inconsistency

    Covidien LLC is recalling 148 procedure kits because the sterilization method used was not consistent with the labeling and approved method.

    Product
    Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT COLECISTECTOMIA- (3)BOX KIT00681 KIT APENDICECTOMIA (4)BOX KIT00897 KIT COLON IZQUIERDO (5)BOX LAPL1 ZESTAW DO CHOLECYSTEKTOMII (6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1041-2019·2019-04-03

    Kendall SCD Express Sterile Sleeves Recalled for Sterility Failure

    COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.

    Product
    Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0627-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement

    FDA is recalling the Covidien Emprint Standard Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0497-2019·2018-12-26

    COVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues

    COVIDIEN LLC is recalling 9,593 Puritan Bennett 980 ventilators worldwide due to a software update affecting external USB drive performance and GUI functionality.

    Product
    Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient popu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0625-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.

    Product
    Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0626-2019·2018-12-26

    FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA is recalling specific lots of the Covidien Emprint Short Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft during use, potentially remaining in the patient.

    Product
    Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2019·2018-12-26

    COVIDIEN Recalls 8Fr Argyle Suction Catheter Kits with Chimney Valve

    COVIDIEN LLC is recalling 32,071 units of 8Fr Argyle Suction Catheter Kits with Chimney Valve, Model 36826, because they were distributed while subject to importation refusal.

    Product
    8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0597-2019·2018-12-19

    COVIDIEN Recalls Salem Sump Stomach Tubes Due to Packaging Error

    COVIDIEN LLC is voluntarily recalling 1,522 Salem Sump Dual Lumen Stomach Tubes because one lot of 10 Fr tubes was incorrectly packaged in 16 Fr pouches.

    Product
    Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2019·2018-11-21

    Medtronic Recalls Parietex Composite Parastomal Mesh Due to Failure Reports

    Medtronic is voluntarily removing Parietex Composite Parastomal Mesh from the market after receiving reports of product failure leading to hernia recurrence.

    Product
    Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2019·2018-10-10

    Kerlix Gauze Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Gauze Rolls due to a potential seal defect that could compromise sterility.

    Product
    Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0018-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Rolls Recalled for Sterility Breach Risk

    COVIDIEN LLC is recalling Dermacea Gauze Fluff Rolls due to a potential seal defect that could compromise sterility.

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0013-2019·2018-10-10

    Kerlix AMD Antimicrobial Bandage Roll Recalled for Sterility Breach Risk

    Coviden LLC is recalling Kerlix AMD Antimicrobial Bandage Rolls due to a potential seal defect that could compromise product sterility.

    Product
    Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Covidien

Irish tax-registered company

Country
Ireland
Founded
2007
Parent company
Medtronic plc

Official website

Source: Wikidata (Q908172), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.