Covidien LLC recalls
127 recalls in our records from 2012 to 2026: 127 FDA medical devices.
Recalls with full detail pages
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Covidien medical device recall: Newport HT70 Ventilator
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus…
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Covidien medical device recall: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable…
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure,…
Earlier and other recalls
These link to the official agency notice.
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Covidien, LLC medical device recall: EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100… Official notice ↗
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
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Covidien, LP medical device recall: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21… Official notice ↗
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to…
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Covidien LLC medical device recall: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code:… Official notice ↗
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
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Covidien, LP medical device recall: Covidien EndoStitch" Polysorb Single Use Loading Unit Official notice ↗
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
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Covidien LLC medical device recall: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor… Official notice ↗
Temperature probe devices lack FDA clearance.
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Covidien LLC medical device recall: COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN… Official notice ↗
Due to customer complaint regarding incorrect display box labeling.
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Covidien LLC medical device recall: HealthCast "Vital Sync" Remote Patient Monitoring System which… Official notice ↗
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient…
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Covidien, LP medical device recall: Covidien Signia" Small Diameter Curved Tip Intelligent Reload Official notice ↗
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for…
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Covidien medical device recall: Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N Official notice ↗
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure,…
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Covidien LP medical device recall: Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm Official notice ↗
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
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Covidien medical device recall: McGrath Mac Video Laryngoscope Official notice ↗
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
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Covidien medical device recall: Covideien McGRATH MAC Video Laryngoscope Official notice ↗
IFU update to address device's battery handling information.
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Covidien medical device recall: Puritan Bennett 500 Series Ventilators Official notice ↗
Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator…
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Covidien, LLC medical device recall: EsoFLIP Official notice ↗
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
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Covidien, LP medical device recall: Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in… Official notice ↗
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
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Covidien, LP medical device recall: Sofsilk Braided Silk sutures Official notice ↗
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over…
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Covidien medical device recall: Medtronic Invos Official notice ↗
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
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Covidien LP medical device recall: Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch Official notice ↗
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
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Covidien, LP medical device recall: Covidien Auto Suture" Structural Balloon Trocar Official notice ↗
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
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Covidien, LP medical device recall: Signia" Small Diameter Curved Tip Intelligent Reload Official notice ↗
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to…
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Covidien medical device recall: Situate Laparotomy Sponge Official notice ↗
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect…
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Covidien LP medical device recall: AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5… Official notice ↗
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the…
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Covidien LP medical device recall: Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK… Official notice ↗
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time,…
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Covidien medical device recall: Covidien Valleylab FT10 Official notice ↗
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
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Covidien medical device recall: Stolen McGRATH MAC Video Laryngoscopes Official notice ↗
Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently…
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Covidien medical device recall: McGrath Mac 2 Official notice ↗
Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
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Covidien medical device recall: Puritan Bennett Cuff Pressure Manager Official notice ↗
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing…
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Covidien LP medical device recall: Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Official notice ↗
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon…
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Covidien LP medical device recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter Official notice ↗
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the…
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Covidien, LLC medical device recall: Covidien Cytosponge Cell Collection Device Official notice ↗
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device…
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Covidien, LLC medical device recall: Medtronic ILLUMISITE Platform Console Official notice ↗
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by…
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Covidien LP medical device recall: VersaOne Reusable Positioning Cannula 8 mm Standard Official notice ↗
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the…
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Covidien medical device recall: Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Official notice ↗
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps…
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Covidien, LP medical device recall: Step Bladeless Trocars Official notice ↗
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead…
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Covidien medical device recall: COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0… Official notice ↗
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
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Covidien, LP medical device recall: Tri-Staple 2.0 Black Intelligent Reload Official notice ↗
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without…
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Covidien, LP medical device recall: Parietex Composite Mesh Polyester with Absorbable Collagen Film Official notice ↗
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and…
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Covidien, LP medical device recall: Dermalon Monofilament Nylon Suture Official notice ↗
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
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Covidien, LLC medical device recall: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology Official notice ↗
The product is labeled with the incorrect expiration date.
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Covidien LP medical device recall: MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter Official notice ↗
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid…
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Covidien, LP medical device recall: Endo Stitch V-Loc 180 Absorbable Reload Official notice ↗
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a…
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Covidien Llc medical device recall: Puritan Bennett 560 Ventilator Official notice ↗
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of…
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Covidien Llc medical device recall: TruClear Hysteroscopic Tissue Removal System Control Unit- designed… Official notice ↗
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
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Covidien, LP medical device recall: EEA Autosuture Circular Stapler with DST Series Technology Official notice ↗
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if…
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Covidien Llc medical device recall: Palindrome Precision Chronic Catheter Official notice ↗
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in…
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Covidien Llc medical device recall: Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm Official notice ↗
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force…
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Covidien, LP medical device recall: SonarMed AirWave Monitor Kit Official notice ↗
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during…
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Covidien Llc medical device recall: LigaSure Blunt Tip Laparoscopic Sealer/Divider Official notice ↗
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue…
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Covidien Llc medical device recall: Covidien Sonicision Battery Charger-intended to charge the Sonicision… Official notice ↗
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
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Covidien Llc medical device recall: Puritan Bennett 980 Series Ventilator Official notice ↗
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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Covidien Llc medical device recall: Covidien Emprint Ablation Catheter with Thermosphere Technology… Official notice ↗
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system…
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Covidien, LP medical device recall: Palindrome RT Chronic Catheter Kit Symmetrical Tip Official notice ↗
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU).
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Covidien Llc medical device recall: Covidien Sonicision Reusable Generator-converts electrical power from… Official notice ↗
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal…
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Covidien, LP medical device recall: Electrostatic Filter Angled Official notice ↗
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide…
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Covidien Llc medical device recall: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm… Official notice ↗
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate…
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Covidien medical device recall: Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical Official notice ↗
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged…
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Covidien, LP medical device recall: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm… Official notice ↗
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety…
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Covidien Llc medical device recall: CF Delivery Dev Caps Bravo x5 Official notice ↗
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate…
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Covidien Llc medical device recall: Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester… Official notice ↗
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right side use.…
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Covidien Llc medical device recall: Covidien TA Auto Suture Vascular Stapler with DST Series Technology… Official notice ↗
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing…
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Covidien Llc medical device recall: Capnostream 35 Portable Respiratory Monitor Official notice ↗
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits"…
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Covidien Llc medical device recall: Puritan Bennett 980 Official notice ↗
In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials,…
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Covidien, LP medical device recall: Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm -… Official notice ↗
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple…
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Covidien Llc medical device recall: Beacon EUS Access System Preloaded Access 90degree Needle sterile Official notice ↗
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not…
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Covidien Llc medical device recall: Multifire VersaTrack Auto Suture Hernia Stapler Official notice ↗
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument…
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Covidien Llc medical device recall: Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W Official notice ↗
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body…
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Covidien Llc medical device recall: Covidien Force TriVerse Electrosurgical Devices Official notice ↗
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
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Covidien LLC medical device recall: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection Official notice ↗
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
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Covidien LLC medical device recall: Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 Official notice ↗
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
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Covidien LLC medical device recall: MAHURKAR and Argyle acute hemodialysis catheters Official notice ↗
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
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Covidien LLC medical device recall: Egia 30 Articulating Med Thick Sulu Official notice ↗
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding,…
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Covidien LLC medical device recall: Covidien Endo Clinch II Auto Suture Grasper Official notice ↗
Sterilization method used was not consistent with the labeling and the approved sterilization method
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Covidien LLC medical device recall: Kendall SCD Express Sterile Sleeves Official notice ↗
The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.
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Covidien, PLC medical device recall: Covidien Force TriVerse electrosurgical device 10 cord-Intended as… Official notice ↗
Potential for the sterile packaging to be compromised
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Covidien LLC medical device recall: 8Fr SAFE GRAD CAT W/Valve Official notice ↗
The product was released into commercial distribution while subject to importation refusal.
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Covidien LLC medical device recall: Covidien Emprint Long Percutaneous Antenna with Thermosphere… Official notice ↗
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip…
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Covidien LLC medical device recall: Puritan Bennett 980 Official notice ↗
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during…
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Covidien LLC medical device recall: Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch Official notice ↗
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The…
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Covidien LLC medical device recall: Parietex Composite Parastomal Mesh Official notice ↗
The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the…
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Covidien LLC medical device recall: EEA Circular Stapler with Tri-Staple Technology Official notice ↗
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation…
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Covidien LLC medical device recall: Kerlix AMD Antimicrobial Bandage Roll Official notice ↗
Potential for product sterility breach due to a compromised or pinched seal defect
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Covidien LLC medical device recall: 400mL Official notice ↗
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
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Covidien LLC medical device recall: Li-ion battery packs used in BIS Vista and BIS View Monitoring… Official notice ↗
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
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Covidien LLC medical device recall: Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21 Official notice ↗
Potential proplylene glycol contamination
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Covidien LLC medical device recall: LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A… Official notice ↗
Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
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Covidien LLC medical device recall: EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology… Official notice ↗
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper…
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Covidien LLC medical device recall: Signia" Power Handle Official notice ↗
Product reportedly shutting down during use.
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Covidien LLC medical device recall: Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series… Official notice ↗
Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.
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Covidien LLC medical device recall: Situate Gauze RF and X-Ray detectable. Product Number:… Official notice ↗
This voluntary recall is being conducted due to the potential for failure to detect the affected Situate" gauze - RF and Xray detectable products by the Situate"…
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Covidien LLC medical device recall: Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA… Official notice ↗
The device cartridge disengaged during use due to manufacturing error.
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Covidien LLC medical device recall: Endo GIA Auto Suture Universal Articulating Loading Unit for use in… Official notice ↗
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
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Covidien LLC medical device recall: GastriSail" Gastric Positioning Device Product Usage: The GastriSail… Official notice ↗
Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastric Positioning device has been used.
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Covidien LLC medical device recall: Covidien Emprint Percutaneous Antenna with Thermosphere Technology Official notice ↗
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip…
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Covidien LP medical device recall: Covidien Vistec" X-Ray Detectable Sponges Official notice ↗
Medtronic is voluntarily recalling two production lots of its Covidien Vistec" x-ray detectable sponges de to possible contamination with human blood caused by handling…
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Covidien LLC medical device recall: Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code:… Official notice ↗
Cotton tip of the device may disengage due to insufficient adhesive
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Covidien LLC medical device recall: Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a… Official notice ↗
Product sterility is compromised due to breach of sterile barrier
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Covidien LLC medical device recall: Premier Guard Sterile Drape For Use with Blair-Port Wand Official notice ↗
Sterility compromised due to breach in sterile barrier
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Covidien LLC medical device recall: Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10 Official notice ↗
Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.
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Covidien LLC medical device recall: Covidien Precision Specimen Container- 4 oz Official notice ↗
Sterility of the outer surface of the container compromised due to packaging defect.
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Covidien LLC medical device recall: Covidien Devon Light Glove packaged in sterile surgical kits… Official notice ↗
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.