Covidien recalls
53 official recalls and safety alerts involving Covidien since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Covidien or the relevant agency.
- 2026-08-26
USCovidien, LLC recalls EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1…
The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.
FDA · DeviceCovidien, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AZ,…Official notice →- 2026-08-19
- US
Covidien, LP recalls V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON…
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 infection, loss of vision if in ophthalmic utilization, or…
FDA · DeviceCovidien, LPUS Nationwide and the countries of Australia, Austria, Belgium, Bulgaria,…Official notice → - 2026-07-08
- US
Covidien LLC recalls Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley…
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
FDA · DeviceCovidien LLCU.S. Nationwide distribution including in the states and territories of AK,…Official notice → - 2026-06-10
- US
Covidien, LP recalls Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
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.
FDA · DeviceCovidien, LPDomestic: Nationwide distribution; International: Austria, Canada, Denmark,…Official notice → - US
Covidien LLC recalls Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Temperature probe devices lack FDA clearance.
FDA · DeviceCovidien LLCUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in…
Due to customer complaint regarding incorrect display box labeling.
FDA · DeviceCovidien LLCWorldwide - U.S.: Nationwide distribution in the state of TX and the countries…Official notice → - 2026-03-18
- US
Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI…
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 monitoring system.
FDA · DeviceCovidien LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, FL,…Official notice → - 2025-11-19
- US
Covidien, LP recalls Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
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 uncontrolled motion.
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2025-07-30
- US
Covidien recalls Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,…
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of MS, TX, FL,…Official notice → - 2025-06-18
- US
Covidien recalls Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU.…
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 necessitating use of an alternate form of ventilation,…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of MA, CT, KS,…Official notice → - 2025-04-02
- US
Covidien recalls Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
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, aspiration, unspecified tissue injury, aspiration,…
FDA · DeviceCovidienOUS distribution only to countries of: France, Germany, Ireland, Italy,…Official notice → - 2024-11-06
- US
Covidien LP recalls Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm…
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
FDA · DeviceCovidien LPWorldwide Distribution: US (Nationwide) and OUS (foreign) to countries of:…Official notice → - 2024-08-28
- US
Covidien recalls Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
IFU update to address device's battery handling information.
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Covidien recalls McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - 2024-08-14
- US
Covidien recalls Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR…
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 over time, the use of these devices for more than…
FDA · DeviceCovidienUS: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR,…Official notice → - 2024-06-19
- US
Covidien, LLC recalls EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
FDA · DeviceCovidien, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AZ,…Official notice → - 2024-06-05
- US
Covidien, LP recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection,…
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
FDA · DeviceCovidien, LPWorldwide - US Nationwide distribution in the state of NJ and the countries of…Official notice → - 2024-05-08
- US
Covidien recalls Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
FDA · DeviceCovidienUS: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI…Official notice → - US
Covidien, LP recalls Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk…
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 time, which could result in harms such as wound…
FDA · DeviceCovidien, LPInternational distribution in the countries of Portugal and Italy.Official notice → - 2024-05-01
- US
Covidien LP recalls Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and…
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
FDA · DeviceCovidien LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2024-04-10
- US
Covidien, LP recalls Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of Albania, Algeria,…Official notice → - US
Covidien, LP recalls Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
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 components in impacted reloads that are not fully…
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide and the countries of France, Hong Kong,…Official notice → - 2024-03-27
- US
Covidien recalls Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to…
FDA · DeviceCovidienUS Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL,…Official notice → - 2024-02-14
- US
Covidien LP recalls AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in…
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 product sterility
FDA · DeviceCovidien LPUS Nationwide distribution in the states of CA, CO, FL, IL, TX.Official notice → - 2024-02-07
- US
Covidien LP recalls Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0…
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, which could result in harms such as wound…
FDA · DeviceCovidien LPWorldwide US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2024-01-10
- US
Covidien recalls Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable
FDA · DeviceCovidienWorldwide distribution - US: Nationwide and surrounding territories.Official notice → - 2023-11-08
- US
Covidien recalls McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
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.
FDA · DeviceCovidienUS: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM…Official notice → - US
Covidien recalls Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in…
- 2023-10-11
- US
Covidien recalls Puritan Bennett Cuff Pressure Manager, REF: 180-03
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 after several uses, which prevents the device from…
FDA · DeviceCovidienUS: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El…Official notice → - 2023-10-04
- US
Covidien LP recalls Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
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 the correct labeling on the catheter body.
FDA · DeviceCovidien LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - 2023-08-23
- US
Covidien LP recalls MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
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 catheter tip. An occluded, partially or fully,…
FDA · DeviceCovidien LPUS Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain…Official notice → - 2023-08-09
- US
Covidien, LLC recalls Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
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 fragments in patient, obstruction, airway obstruction,…
FDA · DeviceCovidien, LLCWorldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the…Official notice → - 2023-07-05
- US
Covidien, LLC recalls Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
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 Medtronic Field Service Engineer.
- 2023-05-03
- US
Covidien LP recalls VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS
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 Cannula and Body components are welded together.
FDA · DeviceCovidien LPWorldwide - US Nationwide distribution in the states of NC and the countries…Official notice → - 2023-04-26
- US
Covidien recalls Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF,…
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories.…
FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of PR, CA, FL,…Official notice → - 2023-04-19
- US
Covidien, LP recalls Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
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 to an unspecified infection or, in the case of…
FDA · DeviceCovidien, LPWorldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA,…Official notice → - 2023-04-05
- US
Covidien recalls COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed are…
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system.
FDA · DeviceCovidienU.S.: AK, AZ, CA, FL, GA, IA, IL, IN, KS MD, MI, MS, NC, NE, NJ, NY, OH, OK,…Official notice → - 2023-03-15
- US
Covidien, LP recalls Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
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 forming staples, and tissue hang-up. These…
FDA · DeviceCovidien, LPWorldwide distribution - US Nationwide distribution in the states of Arkansas,…Official notice → - 2023-03-08
- US
Covidien, LP recalls Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement…
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 failure of implant
FDA · DeviceCovidien, LPUS Distribution to states of: CA, GA, NY and OUS Foreign distribution to…Official notice → - US
Covidien, LP recalls Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11…
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
FDA · DeviceCovidien, LPUS Nationwide Distribution and OUS Foreign distribution to countries of:…Official notice → - 2023-01-18
- US
Covidien, LLC recalls COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
The product is labeled with the incorrect expiration date.
- US
Covidien LP recalls MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No.…
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 return during use.
FDA · DeviceCovidien LPWorldwide distribution. US nationwide including Guam, USVI, and Puerto Rico;…Official notice → - 2022-11-23
- US
Covidien, LP recalls Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L,…
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 portion of the needle to remain in the patient, foreign…
FDA · DeviceCovidien, LPDomestic distribution nationwide. Foreign distribution to Australia Austria…Official notice → - 2022-09-28
- US
Covidien Llc recalls Puritan Bennett 560 Ventilator, PB560, CFN 4096600
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 specific turbine components.
FDA · DeviceCovidien LlcDomestic distribution to one customer in Washington, D.C. Foreign distribution…Official notice → - 2022-08-03
- US
Covidien Llc recalls TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number:…
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.
FDA · DeviceCovidien LlcAZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom…Official notice → - 2022-07-13
- US
Covidien, LP recalls EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.
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 disengaged, could allow the device to transect tissue…
- US
Covidien Llc recalls Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis,…
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 unanticipated fluid return during use.
FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice → - 2022-02-09
- US
Covidien Llc recalls Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular.…
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the…
FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide and the countries of Germany, Israel,…Official notice → - 2022-01-26
- US
Covidien, LP recalls SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
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 setup. The monitor detection of a false sensor cable…
FDA · DeviceCovidien, LPThe devices were distributed to the following US states: CA, CO, FL, IL, KY,…Official notice → - 2022-01-19
- US
Covidien Llc recalls LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
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 could result in the potential for bleeding,…
FDA · DeviceCovidien LlcWorldwide Distribution in the countries of Australia, Austria, Belgium, Czech…Official notice → - 2021-12-15
- US
Covidien Llc recalls Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
- US
Covidien Llc recalls Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery…
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
- 2021-11-17
- US
Covidien Llc recalls Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
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 failure. Use of an affected device in conjunction with…
FDA · DeviceCovidien LlcNo domestic distribution. Foreign distribution to Hong Kong and UK.Official notice →