Covidien LLC

FDA Regulatory Profile

Summary

Total Recalls
482 (68 Class I)
510(k) Clearances
220
Inspections
66
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1557-2026Class IIHealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASJanuary 30, 2026
Z-0486-2026Class IICovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA September 25, 2025
Z-0485-2026Class IICovidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTSeptember 25, 2025
Z-2151-2025Class IICovidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941June 23, 2025
Z-1915-2025Class INewport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70MMay 21, 2025
Z-1390-2025Class IShiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80RFebruary 26, 2025
Z-0257-2025Class IIChameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm September 19, 2024
Z-2636-2024Class IMcGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyJuly 9, 2024
Z-2717-2024Class IICovideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyJuly 9, 2024
Z-2637-2024Class IMcGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyJuly 9, 2024
Z-2446-2024Class IPuritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, June 24, 2024
Z-2038-2024Class IIEsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyApril 25, 2024
Z-1891-2024Class IITri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatrApril 15, 2024
Z-1634-2024Class IIPalindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, March 15, 2024
Z-1635-2024Class IIPalindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin CMarch 15, 2024
Z-1469-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSFebruary 28, 2024
Z-1470-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTFebruary 28, 2024
Z-1466-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLFebruary 28, 2024
Z-1467-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLFebruary 28, 2024
Z-1471-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLFebruary 28, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)December 29, 2025
K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner CanDecember 29, 2025
K250725Hugo™ RAS SystemDecember 3, 2025
K250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube CufflesOctober 6, 2025
K243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal TubeSeptember 25, 2025
K241486Sofsilk™ Coated Braided Silk SutureDecember 3, 2024
K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)August 20, 2024
K241085Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)July 12, 2024
K240572Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM SJuly 1, 2024
K233341Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450,May 20, 2024
K230693BIS™ Advance Monitoring SystemFebruary 26, 2024
K231934GIA™ Stapler with Tri-Staple™ TechnologyOctober 27, 2023
K231240MaxTack™ Motorized Fixation DeviceSeptember 8, 2023
K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135,August 30, 2023
K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyAugust 16, 2023
K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilAugust 16, 2023
K231861EndoflipTM 300 SystemJuly 21, 2023
K223705EndoflipTM 300April 14, 2023
K221629Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)February 22, 2023
K223158LigaSure™ XP Maryland Jaw Sealer/DividerJanuary 23, 2023