Covidien
FDA Regulatory Profile
Covidien appears in FDA public data with 494 recalls — including 68 Class I (most serious) —, 225 510(k) clearances, 66 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2922-2026, Class II) was initiated on June 24, 2026. Its most recent 510(k) clearance was granted on September 15, 2026.
Summary
- Total Recalls
- 494 (68 Class I)
- 510(k) Clearances
- 225
- Inspections
- 66
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2922-2026 | Class II | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX | June 24, 2026 |
| Z-2921-2026 | Class II | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 | June 24, 2026 |
| Z-2918-2026 | Class II | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G | June 24, 2026 |
| Z-2920-2026 | Class II | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 7 | June 24, 2026 |
| Z-2919-2026 | Class II | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P | June 24, 2026 |
| Z-2950-2026 | Class II | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHE | May 13, 2026 |
| Z-2653-2026 | Class II | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Cod | April 23, 2026 |
| Z-2271-2026 | Class II | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 | April 23, 2026 |
| Z-2273-2026 | Class II | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 | April 23, 2026 |
| Z-2272-2026 | Class II | Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 | April 23, 2026 |
| Z-2281-2026 | Class II | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; | April 15, 2026 |
| Z-2261-2026 | Class II | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 | April 15, 2026 |
| Z-1557-2026 | Class II | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBAS | January 30, 2026 |
| Z-0486-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA | September 25, 2025 |
| Z-0485-2026 | Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CT | September 25, 2025 |
| Z-2151-2025 | Class II | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941 | June 23, 2025 |
| Z-1915-2025 | Class I | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M | May 21, 2025 |
| Z-1390-2025 | Class I | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R | February 26, 2025 |
| Z-0257-2025 | Class II | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm | September 19, 2024 |
| Z-2717-2024 | Class II | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | July 9, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261070 | LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | September 15, 2026 |
| K260907 | BIS Advance pEEG Module | August 13, 2026 |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular | July 1, 2026 |
| K253984 | Instrument Exit Point on Touch Surgery Aide | June 4, 2026 |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | May 1, 2026 |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Can | December 29, 2025 |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | December 29, 2025 |
| K250725 | Hugo RAS System | December 3, 2025 |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffles | October 6, 2025 |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube | September 25, 2025 |
| K241486 | Sofsilk Coated Braided Silk Suture | December 3, 2024 |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044) | August 20, 2024 |
| K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | July 12, 2024 |
| K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM S | July 1, 2024 |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, | May 20, 2024 |
| K230693 | BIS Advance Monitoring System | February 26, 2024 |
| K231934 | GIA Stapler with Tri-Staple Technology | October 27, 2023 |
| K231240 | MaxTack Motorized Fixation Device | September 8, 2023 |
| K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, | August 30, 2023 |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil | August 16, 2023 |