Covidien, LLC
Covidien, LLC holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2026, with 340 FDA device recalls on record.
Top product codes for Covidien, LLC
FDA recalls by Covidien, LLC
10 most recent of 340- Z-2273-2026 — Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
- Z-2653-2026 — 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 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.
- Z-2272-2026 — Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
- Z-2271-2026 — Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
- Z-2261-2026 — 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 (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
- Z-1557-2026 — 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 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
- Z-2038-2024 — EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
- Z-2282-2023 — Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
- Z-2008-2023 — Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
- Z-0955-2023 — COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Covidien, LLC
- K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) +1 more
- K253984 — Instrument Exit Point on Touch Surgery Aide
- K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)
- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula +4 more
- K250725 — Hugo RAS System
- K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- K243785 — Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
- K241085 — Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)
- K240572 — Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10) +4 more
- K233341 — Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
- K230693 — BIS Advance Monitoring System
- K231861 — EndoflipTM 300 System
- K223705 — EndoflipTM 300
- K223158 — LigaSure XP Maryland Jaw Sealer/Divider
- K213911 — Microstream CO2 NanoPod
- DEN220006 — ProdiGI
- K212555 — Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
- K213518 — CARESCAPE CO2 Microstream parameter
- K203150 — Cool-tip RF Ablation System E Series
- K213602 — Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
- K211561 — INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
- K212301 — Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
- K210338 — Edge Insulated Blade Electrode
- K202917 — LigaSure Exact Dissector, Nano-coated
- K202874 — Puritan Bennett Cuff Pressure Manager
- K203303 — Emprint SX Ablation Platform with Thermosphere Technology
- K193056 — Puritan Bennett 980 Series Ventilator System
- K200796 — Emprint Ablation System with Thermosphere Technology
- K201179 — GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
- K200427 — Sonicision Cordless Ultrasonic Dissector
- K200146 — HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
- K193356 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K193232 — Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
- K192302 — Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter
- K192038 — Emprint Visualization Application
- K191394 — ILLUMISITE Platform
- K182868 — INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
- K182451 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K181020 — Cytosponge Cell Collection Device
- K180485 — Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
- K180037 — Beacon EUS Access System
- K180149 — Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
- K180192 — Emprint Ablation Visualization Application
- K173244 — superDimension Navigation System V7.2
- K173559 — Barrx SB RFA Endoscopic Catheter
- K172757 — Valleylab FX8 Electrosurgical Platform
- K171066 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K163537 — Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
- K163654 — VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
- K170170 — Valleylab FT10 Electrosurgical Platform
- K162802 — Barrx Anorectal RFA Wand
- K163105 — Emprint Ablation System
- K163098 — Tri-Staple 2.0 Intelligent Cartridge
- K160290 — Valleylab REM Polyhesive Infant Patient Return Electrode
- K160654 — GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
- K152794 — Cytosponge Cell Collection Device
- K160360 — Barrx FLEX RFA Energy Generator
- K153371 — Sonicision Cordless Ultrasonic Dissection Device
- K152586 — Beacon Fine Needle Fiducial System
- K151376 — superDimension Navigation System
- K150251 — Barrx Anorectal RFA Wand
- K151659 — ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
- K151356 — Spacemaker Pro Access and Dissector System
- K151163 — Signia Loading Unit, Tri-Staple 2.0 Cartridge
- K142839 — GenCut Core Biopsy System
- K143654 — Valleylab LS10 Generator
- K142865 — Nellcor Bedside SpO2 Patient Monitoring System
- K143598 — Lapro-Clip Auto Suture Reusable Long Clip Applier
- K142695 — Cytosponge Cell Collection Device
- K143091 — Surgisleeve Wound Protector
- K142654 — Fortrex 0.035 OTW PTA Balloon Catheter
- K141801 — HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
- K142198 — BNX Fine Needle Aspiration System
- K141542 — NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
- K142364 — Barrx RFA Self Sizing Balloon Catheter
- K142048 — EMPRINT PROCEDURE PLANNING APPLICATION
- K133821 — EMPRINT ABLATION SYSTEM
- K133762 — ENDO GIA(TM) EXTRA LONG ADAPTER
- K130357 — SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
- K132493 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
- K130623 — BARRX CHANNEL RFA ENDOSCOPIC CATHETER
- K130782 — ACCUMESH DEPLOYMENT SYSTEM
- K123066 — ACCUMESH DEPLOYMENT SYSTEM
- K120773 — NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
- K120605 — PERMACOL SURGICAL IMPLANT
- K121139 — ACCUMESH DEPLOYMENT SYSTEM
- K120863 — WHOLEY GUIDE WIRE SYSTEM
- K103052 — V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
- K102737 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Data sourced from openFDA. This site is unofficial and independent of the FDA.