Covidien
Covidien holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2024, with 21 FDA device recalls on record.
Top product codes for Covidien
FDA recalls by Covidien
10 most recent of 21- Z-2151-2025 — Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
- Z-1915-2025 — 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. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70PM-WW-UK, HT70PM-SY-EU, HT70PM-WWNA. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.
- Z-1390-2025 — Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
- Z-2717-2024 — Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
- Z-2636-2024 — McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
- Z-2637-2024 — McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
- Z-2446-2024 — Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01, PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02, PURITAN BENNETT 560 VENTILATOR APAC/4096600-03, Puritan Bennett 560 Ventilator LATAM/4096600-04, Puritan Bennett 560 Ventilator EMEA/4096600-05, Puritan Bennett 560 Ventilator CAN ANZ/4096600-06, Puritan Bennett 540 Ventilator USA/4097100 Puritan Bennett 520 Ventilator/4098300, Puritan Bennett 520 Ventilator EU-DIV/4098300-01, Puritan Bennett 520 Ventilator Japan/4098300-02, Puritan Bennett 520 Ventilator APAC/4098300-03, Puritan Bennett 520 Ventilator EMEA/4098300-05, Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06, DL4096600 DL PB560 VENTILATOR/DL4096600, DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06, REFURBISHED PB540 VENTILATOR/DL4097100, Puritan Bennett 540 Ventilator Refurbished/DS4097100
- Z-1330-2024 — Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- Z-1732-2024 — Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
- Z-1731-2024 — Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
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
1–100 of 130- K241486 — Sofsilk Coated Braided Silk Suture
- K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
- K231934 — GIA Stapler with Tri-Staple Technology
- K231240 — MaxTack Motorized Fixation Device
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
- K231491 — TA Stapler and Loading Unit with DST Series Technology
- K232126 — EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil
- K221629 — Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)
- K221771 — EEA Circular Stapler with Tri-Staple Technology
- K222641 — Signia Small Diameter Reloads Including Regular (Round) Tip Version
- K221003 — Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
- K220540 — ProGrip Self-Gripping Polypropylene Mesh
- K213818 — VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
- K221013 — GIA Auto Suture Stapler with DST Series Technology
- K221005 — EEA Circular Stapler with Tri-Staple Technology
- K221006 — GIA Stapler with Tri-Staple Technology
- K203762 — Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
- K202507 — EEA Circular Stapler with Tri-Staple Technology
- K202701 — GIA Stapler with Tri-Staple Technology
- K202864 — Tri-Staple 2.0 Reloads
- K201805 — VersaOne Reusable Positioning Trocar System
- K201672 — Signia Stapler (with new software)
- K193077 — Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
- K192720 — GIA Stapler with Tri-Staple Technology
- K192330 — EEA Circular Stapler with Tri-Staple Technology
- K191070 — Signia Small Diameter Reloads
- K191601 — Valleylab FT10 Electrosurgical Platform
- K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube
- K182475 — Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
- K182772 — Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil
- K180622 — Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
- K180496 — TruClear Elite Hysteroscope
- K180915 — Sonicision Reusable Sterilization Tray
- K181085 — LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
- K181389 — Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
- K173281 — LigaSure Exact Dissector, Nano-coated
- K173270 — Tri-Staple 2.0 Reinforced Reload
- K172361 — EEA Circular Stapler with Tri-Staple Technology
- K172482 — The Nellcor pulse oximetry monitor interface cable
- K162738 — Puritan Bennett 980 Ventilator System
- K170869 — LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
- K170348 — Signia Four-Bay Smart Charger (to be used with Signia Stapler)
- K163620 — Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
- K163055 — Reprocessed Kendall SCD Express Foot Cuff
- K163102 — ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm
- K160718 — Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
- K162941 — Ligasure Blunt Tip, Sealer/Divider, Nano-coated
- K162584 — VersaOne Bladeless Trocar
- K161804 — LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
- K162047 — LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
- K161347 — Signia sterilization tray
- K161963 — Monoject Enteral Syringe with ENFit Connector
- K161105 — Reprocessed Compression Garments
- K160331 — LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
- K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
- K161045 — Monoject
- K160539 — BiZact Open Sealer/Divider
- K160419 — Monoject Enteral Feeding Syringe with ENFit Connector
- K160176 — Signia Stapler
- K160230 — VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm
- K152149 — VersaOne Bladed Trocar 5mm
- K151381 — Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
- K150835 — LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
- K152565 — Auto Suture Locking Trocar
- K150711 — Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
- K143644 — Premium Surgiclip¿; Endo Clip¿; AcuClip¿
- K151649 — Valleylab FT10 Electrosurgical Platform
- K152286 — LigaSure Curved, Small Jaw, Open Sealer/Divider
- K150735 — Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot
- K150844 — Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula
- K150084 — Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector
- K151548 — VersaOne Bladed Trocar, VersaOne Bladeless Trocar
- K142934 — CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
- K143263 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
- K143506 — BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES) +6 more
- K143018 — Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors
- K141518 — Nellcor Bedside Respiratory Patient Monitoring System
- K143088 — GastriSail Gastric Positioning System
- K142296 — Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula +1 more
- K142128 — KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
- K142298 — Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
- K142656 — Surgical Gut Suture
- K142929 — Ligasure Blunt Tip Sealer/Divider
- K142335 — RapidVac Smoke Evacuator System
- K141479 — KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
- K143161 — Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)
- K142547 — Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm
- K142869 — Premium Surgiclip III
- K141153 — LIGASURE; CURVED SMALL JAW SEALER/DIVIDER, 5MM BLUNT TIP SEALER/DIVIDER, MARYLAND JAW ONE STEP STEALER/DIVIDERS, CURVED
- K141858 — CLOSURERFG RADIOFREQUENCY GENERATOR
- K140813 — REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
- K140339 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
- K123555 — KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
- K140609 — RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
- K140064 — SURGISLEEVE WOUND PROTECTOR
- K131252 — PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
- K130320 — BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
- K133938 — ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
- K132604 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
- K132567 — ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.