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.

226–250 of 341

  • SevereFDA (Devices)·Z-2537-2015·2015-09-09

    Recall of Mahurkar Acute Dialysis Catheters Due to Sterility Concerns

    Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.

    Product
    MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2545-2015·2015-09-09

    MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage

    Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.

    Product
    MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2527-2015·2015-09-09

    Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2546-2015·2015-09-09

    MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage

    Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could cause burns or reduced therapy.

    Product
    MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2534-2015·2015-09-09

    Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2533-2015·2015-09-09

    Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.

    Product
    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2536-2015·2015-09-09

    MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise

    FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.

    Product
    MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2526-2015·2015-09-09

    Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2535-2015·2015-09-09

    MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise

    Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.

    Product
    MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2015·2015-09-09

    Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling specific Mahurkar Elite Acute Dual Lumen Catheter Trays because their sterility may be compromised.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    The FDA is recalling Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. This Class II recall affects a specific lot distributed nationwide.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular acces
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 53 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2015·2015-09-09

    Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intrav
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    The FDA is recalling 67 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The product was distributed nationwide.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2015·2015-09-09

    Monoject Saline Flush Recall Due to Potential Sterility Compromise

    Covidien LLC is recalling Monoject 0.9% Saline Flush Prefill Double Pouches because sterility may be compromised.

    Product
    Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2015·2015-09-02

    Recall of Infant Heel Warmers Due to Potential Breakage and Spillage

    The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.

    Product
    Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2015·2015-09-02

    FDA Recalls Covidien Infant Heel Warmers Due to Breakage Risk

    The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.

    Product
    Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2111-2015·2015-07-29

    FDA Recalls Sterile Surgical Kits with Compromised Gloves

    The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.

    Product
    ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2116-2015·2015-07-29

    FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves

    The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.

    Product
    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2015·2015-07-29

    FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves

    The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain splits or holes that compromise sterility.

    Product
    Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2107-2015·2015-07-29

    FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves

    The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.

    Product
    Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2015·2015-07-29

    Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.

    Product
    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2015·2015-07-29

    Recall of Sterile Major Kits with Defective Devon Light Gloves

    FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.

    Product
    Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2118-2015·2015-07-29

    FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise

    FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.

    Product
    Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA
    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.