The Recall Desk

Manufacturer

Covidien, LP

131 recalls in our database name Covidien, LP as the manufacturing or recalling firm.

What the numbers show

Total
131
Critical
1
Severe
50
Most recent
2026-08-19

Of the 131 recalls from Covidien, LP we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 50 (38%) 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.

76–100 of 131

  • HighFDA (Devices)·Z-0514-2022·2022-01-26

    SonarMed AirWave Monitor Kit recall due to alarm and sensor detection failures

    Covidien is recalling 66 SonarMed AirWave Monitor Kits because the alarm may fail to sound and sensors may be incorrectly detected as disconnected, potentially causing the monitor to stop monitoring patients without alerting staff.

    Product
    SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2359-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling and Instructions Enhancement

    Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2361-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Labeling Enhancement Withdrawal

    Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2370-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit recalled for labeling and instruction updates

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2373-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kit Withdrawn for Labeling Enhancements

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2360-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit withdrawn for labeling and instruction improvements

    Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2365-2021·2021-09-08

    Palindrome RT Repair Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2369-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).

    Product
    Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2372-2021·2021-09-08

    Palindrome Precision RT Chronic Catheter Kits Withdrawn for Labeling and Instruction Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2358-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2362-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling Enhancement

    Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2367-2021·2021-09-08

    Palindrome RT Repair Kit voluntary withdrawal for labeling enhancements

    Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.

    Product
    Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2366-2021·2021-09-08

    Palindrome RT Repair Kit Withdrawn for Enhanced Labeling and Instructions

    Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.

    Product
    Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2371-2021·2021-09-08

    Palindrome Precision RT Catheter Kit Withdrawn for Labeling and Instruction Enhancements

    Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2375-2021·2021-09-08

    Covidien Palindrome Chronic Catheter Kits Withdrawn to Enhance Labeling and Instructions

    Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2374-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Withdrawn for Labeling Updates

    Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.

    Product
    Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2363-2021·2021-09-08

    Palindrome RT Chronic Catheter Kit Voluntary Withdrawal for Labeling and Instruction Updates

    Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.

    Product
    Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1869-2021·2021-06-23

    HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations

    Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.

    Product
    HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2021·2021-06-23

    Covidien Respiratory Filters Recalled for Sterilization Process Deviations

    Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.

    Product
    Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2021·2021-06-23

    Electrostatic Filter Angled recalled for sterilization validation deviations

    Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.

    Product
    Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2021·2021-06-23

    Mechanical respiratory filter recalls due to sterilization process deviation

    Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.

    Product
    Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2021·2021-04-21

    Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1384-2021·2021-04-21

    Recall of Covidien Signia Vascular Stapler Reloads Due to Safety Interlock Failure

    FDA recalls 11,391 units of Covidien Signia vascular stapler reloads because a safety interlock may fail, allowing empty reloads to fire and cause tissue injury.

    Product
    Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
    Category
    Medical Device
    Distribution
    Distributed nationwide