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.

126–150 of 341

  • HighFDA (Devices)·Z-0014-2019·2018-10-10

    Kerlix Bandage Rolls Recalled for Potential Sterility Breach

    COVIDIEN LLC is recalling Kerlix Bandage Rolls due to a seal defect that may compromise sterility. The recall covers 2,730,821 units distributed nationwide.

    Product
    Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 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-0017-2019·2018-10-10

    COVIDIEN Dermacea Gauze Fluff Roll Recalled for Sterility Breach Risk

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

    Product
    Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 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-0070-2019·2018-10-10

    Coviden EEA Circular Stapler Recalled for Potential Tissue Gap Defect

    Coviden is recalling 1,902 EEA Circular Staplers with Tri-Staple Technology due to a potential defect that may cause incomplete staple formation or device retention in tissue.

    Product
    EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2019·2018-10-10

    Kerlix Bandage Roll Recalled for Potential Sterility Breach

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

    Product
    Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 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-3205-2018·2018-09-26

    Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings

    Coviden is recalling temperature sensing Foley catheters that may display lower body temperature measurements than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-3203-2018·2018-09-26

    Coviden Recalls Defective Temperature Sensing Foley Catheters

    Coviden is recalling specific sterile Foley catheter trays because the temperature sensors may display lower body temperature readings than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-3206-2018·2018-09-26

    Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings

    Coviden is recalling temperature sensing Foley catheters because they may display lower body temperature readings than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2958-2018·2018-09-05

    FDA Recalls Li-ion Battery Packs for BIS Monitoring Systems

    The FDA is recalling Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems due to a Class II safety issue.

    Product
    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2601-2018·2018-08-08

    Polysorb Suture Recalled for Potential Propylene Glycol Contamination

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential propylene glycol contamination. The recall affects 972 units distributed in California, New York, and Texas.

    Product
    Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2427-2018·2018-07-18

    FDA Recalls LigaSure Exact Dissector Nano Coated Due to Sterile Breach

    FDA is recalling 936 units of LigaSure Exact Dissector Nano Coated instruments because sterile pouches were found with punctures.

    Product
    LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1528-2018·2018-05-02

    EEA Hemorrhoid Stapler Recalled for Potential Welding Defect

    FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2018·2018-05-02

    Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect

    Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2018·2018-04-04

    Signia Power Handle Recalled for Shutting Down During Surgical Use

    Covidien LLC is recalling 2,121 Signia Power Handles because they reportedly shut down during use. The devices are used in various surgical procedures.

    Product
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2018·2018-04-04

    Puritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect

    FDA is recalling 15,885 rechargeable lithium-ion batteries for Puritan Bennett 980 ventilators due to incorrect firmware that may prevent full charging.

    Product
    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2018·2018-03-28

    Situate Gauze Recalled for Potential Failure to Detect by Console

    Covidien LLC is voluntarily recalling Situate Gauze RF and X-Ray detectable products due to a manufacturing error that may prevent detection by the Situate console.

    Product
    Situate Gauze RF and X-Ray detectable. Product Number: G0804-16P02CN-1 Situate premium cotton are single use cotton disposable that must be used with the Situate delivery system. The disposable have an attached RF Tag, which is an electrically passive inductor like device t
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0640-2018·2018-02-28

    GastriSail Gastric Positioning Device Recalled Due to Perforation Reports

    FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.

    Product
    GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0636-2018·2018-02-28

    FDA Recalls Endo GIA Auto Suture Units Due to Safety Interlock Failure

    The FDA is recalling 3,816 Endo GIA Auto Suture Universal Articulating Loading Units because the safety interlock may fail, allowing an empty unit to be fired a second time.

    Product
    Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0558-2018·2018-02-14

    Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

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

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0557-2018·2018-02-14

    Recall of Covidien Emprint Percutaneous Antenna Due to Tip Disengagement

    FDA Class II recall of Covidien Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft and remain in the patient.

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0556-2018·2018-02-14

    Recall of Emprint Percutaneous Antenna Due to Tip Disengagement

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

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0560-2018·2018-02-14

    Recall of Emprint Percutaneous Antenna Due to Tip Disengagement

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

    Product
    Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
    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.