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.

1–25 of 341

  • ModerateFDA (Devices)·Z-2950-2026·2026-08-26

    EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags

    FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.

    Product
    EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2653-2026·2026-07-08

    Covidien Shiley Disposable Decannulation Plug product labeling error

    Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.

    Product
    Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2272-2026·2026-06-10

    Covidien Mon-a-Therm general purpose temperature probes lack FDA clearance

    Covidien Mon-a-Therm General Purpose Temperature Probes, REF 90044, are being recalled because the devices lack FDA clearance. 1,775 units are affected.

    Product
    Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2271-2026·2026-06-10

    Covidien esophageal stethoscope temperature sensors lack FDA clearance

    Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.

    Product
    Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2273-2026·2026-06-10

    Covidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance

    Covidien Mon-a-Therm general purpose temperature probes in size 9 Fr, REF 90050, are being recalled because the devices lack FDA clearance. 128,900 units are affected.

    Product
    Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2261-2026·2026-06-10

    Shiley tracheostomy tubes recalled over incorrect display box labeling

    Covidien Shiley Tracheostomy Tubes with inner cannula, REF 6FEN, are being recalled following a customer complaint about incorrect display box labeling. 1,002 units are affected.

    Product
    COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1557-2026·2026-03-18

    Vital Sync remote monitoring may not receive bedside monitor alarms

    Covidien is recalling the HealthCast Vital Sync Remote Patient Monitoring System after complaints that alarms from the primary patient bedside monitor were not transmitted to or received by the remote system.

    Product
    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 /
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2024·2024-06-19

    EsoFLIP 30mm Balloon Dilation Catheter Recalled for Measurement Inaccuracy

    Covidien is recalling EsoFLIP 30mm balloon dilation catheters due to saline conductivity issues that may cause inaccurate esophageal measurements, potentially leading to patient harm.

    Product
    EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2282-2023·2023-08-09

    Covidien Cytosponge Cell Collection Device Recall Due to Sponge Detachment Risk

    Covidien is recalling certain Cytosponge Cell Collection Devices and Kits because the sponge may detach from the string during removal, potentially causing device fragments, obstruction, and aspiration in patients.

    Product
    Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2023·2023-07-05

    ILLUMISITE Platform Console Incorrectly Converted with Non-Supplied Power Components

    A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.

    Product
    Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0955-2023·2023-01-18

    COVIDIEN Emprint Ablation Catheter recalled for incorrect expiration date

    COVIDIEN Emprint Ablation Catheters (Lot 520200) are recalled because they are labeled with an incorrect expiration date. The 21 affected units were distributed to Hong Kong.

    Product
    COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1775-2022·2022-09-28

    Puritan Bennett 560 Ventilator Recalled for Loss of Gas Supply

    Covidien is recalling the Puritan Bennett 560 Ventilator due to a manufacturing error in turbine components that causes loss of gas supply and device inoperability. Six incidents have been confirmed from customers outside the United States.

    Product
    Puritan Bennett 560 Ventilator, PB560, CFN 4096600
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1467-2022·2022-08-03

    TruClear Hysteroscopic Tissue Removal Control Unit Electrical Failure

    Covidien is recalling 33 TruClear Hysteroscopic Tissue Removal System Control Units due to electrical component failure causing loss of device function during surgery. The affected units were distributed to multiple U.S. states and foreign countries.

    Product
    TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
    Category
    Medical Device
    Distribution
    15 states
  • CriticalFDA (Devices)·Z-1319-2022·2022-07-13

    Palindrome HSI Chronic Catheter Recalled for Potential Hub Leaking

    Covidien is recalling Palindrome HSI Chronic Catheters due to a potential leaking condition in the catheter hub that may cause unanticipated fluid return during dialysis. Approximately 13,526 units distributed worldwide are affected.

    Product
    Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1320-2022·2022-07-13

    Dialysis Catheters Recalled for Potential Fluid Leakage from Hub Defect

    Covidien is recalling Mahurkar Chronic Carbothane dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use. Approximately 132,443 units distributed worldwide are affected.

    Product
    Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1316-2022·2022-07-13

    Palindrome Chronic Catheter recalled due to potential hub leakage

    Covidien is recalling Palindrome Chronic Catheters due to a potential leaking condition in the hub that may cause unexpected fluid return during use.

    Product
    Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1313-2022·2022-07-13

    Palindrome Precision H Chronic Catheter Recalled for Potential Hub Leakage

    Covidien is recalling certain Palindrome Precision H Chronic Catheters because the hub may leak, causing unexpected fluid to flow back during use. This FDA Class I recall affects 26,675 units distributed globally.

    Product
    Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1314-2022·2022-07-13

    Palindrome Precision SI Chronic Catheters Recalled for Potential Hub Leaking

    Covidien recalls Palindrome Precision SI chronic dialysis catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during use.

    Product
    Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1312-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheter Hub Leak Risk

    Palindrome Precision Chronic Catheters used for dialysis may leak due to a flaw in the hub component, potentially allowing unintended fluid to escape during treatment.

    Product
    Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1317-2022·2022-07-13

    Palindrome H Chronic Catheters Recalled for Potential Hub Leaking

    Palindrome H Chronic Catheters are being recalled due to a potential leaking condition in the catheter hub that may result in unanticipated fluid return during hemodialysis treatment. Affected units have been distributed worldwide.

    Product
    Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1315-2022·2022-07-13

    Palindrome Precision Chronic Dialysis Catheters Risk Fluid Leakage Due to Hub Defect

    Covidien recalls 25,765 Palindrome Precision HSI Chronic Catheters due to a defect in the hub that may cause unintended fluid leakage during dialysis treatment.

    Product
    Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2022·2022-07-13

    Palindrome SI Chronic Dialysis Catheters Recalled for Hub Leaking Risk

    Covidien is recalling 2,462 units of Palindrome SI Chronic Catheters due to a potential leaking condition in the hub that may cause unanticipated fluid return during treatment.

    Product
    Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2022·2022-02-09

    Chameleon PTA Balloon Catheter difficult protector sleeve removal risk

    The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.

    Product
    Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2022·2022-01-19

    LigaSure Blunt Tip Laparoscopic Sealer Devices Recalled for Jaw Opening Defect

    Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.

    Product
    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0344-2022·2021-12-15

    Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
    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.