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Covidien

FDA Regulatory Profile

Covidien appears in FDA public data with 488 recalls — including 68 Class I (most serious) —, 223 510(k) clearances, 66 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2272-2026, Class II) was initiated on April 23, 2026. Its most recent 510(k) clearance was granted on July 1, 2026.

Summary

Total Recalls
488 (68 Class I)
510(k) Clearances
223
Inspections
66
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2272-2026Class IICovidien Mon-a-Therm General Purpose Temperature Probe REF: 90044April 23, 2026
Z-2271-2026Class IICovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042April 23, 2026
Z-2273-2026Class IICovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050April 23, 2026
Z-2653-2026Class IICovidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product CodApril 23, 2026
Z-2281-2026Class IICovidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;April 15, 2026
Z-2261-2026Class IICOVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 April 15, 2026
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-2717-2024Class IICovideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyJuly 9, 2024
Z-2636-2024Class IMcGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyJuly 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

Recent 510(k) Clearances

K-NumberDeviceDate
K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular July 1, 2026
K253984Instrument Exit Point on Touch Surgery™ AideJune 4, 2026
K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)May 1, 2026
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
K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler AnvilAugust 16, 2023
K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyAugust 16, 2023
K231861EndoflipTM 300 SystemJuly 21, 2023

FDA data resources