Covidien, LLC FDA Recalls

47 recalls on file across devices, 25 of them Class I and 26 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 EClass IIMay 13, 2026The system's 24-hour usage limit results in catheters incorr	The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable	Class IIDevices	May 13, 2026
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050Class IIApr 23, 2026Temperature probe devices lack FDA clearance.	Temperature probe devices lack FDA clearance.	Class IIDevices	Apr 23, 2026
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044Class IIApr 23, 2026Temperature probe devices lack FDA clearance.	Temperature probe devices lack FDA clearance.	Class IIDevices	Apr 23, 2026
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042Class IIApr 23, 2026Temperature probe devices lack FDA clearance.	Temperature probe devices lack FDA clearance.	Class IIDevices	Apr 23, 2026
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Class IIApr 23, 2026Due to product labeling incorrectly including the symbol ind	Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as t	Class IIDevices	Apr 23, 2026
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intClass IIApr 15, 2026Due to customer complaint regarding incorrect display box la	Due to customer complaint regarding incorrect display box labeling.	Class IIDevices	Apr 15, 2026
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03Class IIJan 30, 2026Due to complaints and investigations stating that alarms fro	Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alar	Class IIDevices	Jan 30, 2026
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyClass IIApr 25, 2024Due to saline conductivity issues, their is a potential that	Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophag	Class IIDevices	Apr 25, 2024
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USClass IIJun 2, 2023Cell Collection Device may be at increased risk of the spong	Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the	Class IIDevices	Jun 2, 2023
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CSClass IIMay 22, 2023Single ILLUMISITE Platform Console was converted from a 220-	Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non	Class IIDevices	May 22, 2023
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1Class IINov 23, 2022The product is labeled with the incorrect expiration date.	The product is labeled with the incorrect expiration date.	Class IIDevices	Nov 23, 2022
Puritan Bennett 560 Ventilator, PB560, CFN 4096600Class IIAug 19, 2022Medtronic has confirmed six reports from customers outside t	Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due t	Class IIDevices	Aug 19, 2022
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialyClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, Class IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresiClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodiaClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodiClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusiClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusionClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apherClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusioClass IJun 8, 2022There is a potential leaking condition within the hub of spe	There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-	Class IDevices	Jun 8, 2022
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue remoClass IIJun 7, 2022Electrical component failure within the control unit. The ob	Electrical component failure within the control unit. The observed failure mode is a loss of function of the d	Class IIDevices	Jun 7, 2022
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; CClass IIDec 17, 2021The firm has received six (6) complaint reports from custome	The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon prot	Class IIDevices	Dec 17, 2021
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837Class IIDec 6, 2021Customers reported that the device jaws were difficult to op	Customers reported that the device jaws were difficult to open or would not open following application on tiss	Class IIDevices	Dec 6, 2021
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information oClass IINov 12, 2021Intermittent risk of electric shock to users if an affected	Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or by	Class IIDevices	Nov 12, 2021
Puritan Bennett 980 Series Ventilator, 980X1PLDIPCClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENNISBClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENDIPCClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X2ESDIECClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980S3ENDICUClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator,980X1ENAIQCClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980S1ENDICUClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENDIUUClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X1JADIJJClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X3ENDIUUClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980U1ESDIUCClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980U3ESDIUUClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980A1ENNISBClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980A3ENNISBClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980X3JADIJJClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Puritan Bennett 980 Series Ventilator, 980U1ENASAAClass INov 4, 2021Manufacturing assembly error where a capacitor within the ve	Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may caus	Class IDevices	Nov 4, 2021
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1Class IISep 29, 2021The firm identified an error in the device temperature monit	The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt ene	Class IIDevices	Sep 29, 2021
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive theClass IIJun 23, 2021Potential for a manufacturing assembly error-may result in a	Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activati	Class IIDevices	Jun 23, 2021
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple linClass IIMar 23, 2021Potential for the pouch to contain an extra laminate layer,	Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to	Class IIDevices	Mar 23, 2021
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measuremeClass IIFeb 26, 2021The capsule may fail to attach to the esophageal mucosa, whi	The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsu	Class IIDevices	Feb 26, 2021
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measuremenClass IIFeb 26, 2021The capsule may fail to attach to the esophageal mucosa, whi	The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsu	Class IIDevices	Feb 26, 2021
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of iClass IIJan 13, 2021incorrect device is contained in the package. The packaging	incorrect device is contained in the package. The packaging label indicates that the device is for left side u	Class IIDevices	Jan 13, 2021