Covidien
FDA adverse event reports naming Covidien as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COVIDIEN.
- Total reports
- 56,472
- Deaths
- 631
- Injuries
- 10,327
- Malfunctions
- 44,727
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Ventilator, Continuous, Facility UseCBK13,054
- Pump, Infusion, EnteralLZH6,820
- Staple, ImplantableGDW3,676
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI3,626
- Laparoscope, General & Plastic SurgeryGCJ2,079
- Tubes, Gastrointestinal (And Accessories)KNT1,512
- Catheter, Hemodialysis, ImplantedMSD1,413
- Catheter, Angioplasty, Peripheral, TransluminalLIT1,312
- Product code KOGKOG1,180
- Needle, Hypodermic, Single LumenFMI1,114
Recent recalls
- 2026-08-14Open, ClassifiedUnder Investigation by firm
EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684
Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.
- 2026-08-07Open, ClassifiedEquipment maintenance
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM0003 V-LOC* 90 4-0 CLR 15CM P12X12 VLOCM0003 VLOCM0013 V-LOC* 90 4-0 CLR 30CM P12X12 VLOCM0013 VLOCM0024 V-LOC* 90 3-0 CLR 45CM P12X12 VLOCM0024 VLOCM0123 V-LOC* 90 4-0 CLR 45CM P14X12 VLOCM0123 VLOCM0315 V-LOC* 90 2-0 VIO 30CM GS21 VLOCM0315 VLOCM0603 V-LOC* 90 4-0 VIO 15CM V20X12 VLOCM0603 VLOCM0604 V-LOC* 90 3-0 VIO 15CM V20X12 VLOCM0604 VLOCM1203 V-LOC* 90 4-0 VIO 15CM CV15 VLOCM1203 VLOCM2115 V-LOC* 90 2-0 VIO 30CM GS22 VLOCM2115
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- 2026-08-07Open, ClassifiedEquipment maintenance
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX BYPASS DR LAGAE BOX01482V2 BOX BYPASS KIT DEZEMBER 2025 BOX09222V1 BOX BYPASS KIT NEU BOX 003 BOX08767V1 BOX GASTRIC BYPASS JAWBYPASS2 BOX GASTRIC BYPASS SIGNIA BOX02191V11 BOX GASTRICBYPASS KIT V4 BOX06863V4 BOX GB BOX MET LHOOK PST04884V3 BOX GB ZONDER ENDOHERNIA EGIA PST04884V6 BOX GBP SIGNIA BOX08506V2 BOX KIT COLON IHS KIT00625V1 BOX KIT HERNIA HIATO IHS KIT01026V1 BOX LAP HERNIE INGUNIAL RIGHT BOX00051V4 BOX NEW GBP KIT PST03130V2 BOX ZESTAW DO BARIATRII GB UCKGB5 BOX ZESTAW DO RYGB WEJRYGB3 VLOCL0013 V-LOC* 180 4-0 CLR 30CM P12 VLOCL0013 VLOCL0014 V-LOC* 180 3-0 CLR 30CM P12 VLOCL0014 VLOCL0023 V-LOC* 180 4-0 CLR 45CM P12 VLOCL0023 VLOCL0024 V-LOC* 180 3-0 CLR 45CM P12 VLOCL0024 VLOCL0306 V-LOC 180 DEVICE 0 15CM GS-21 VLOCL0306 VLOCL0316 V-LOC* 180 0 GRN 30CM GS21X12 VLOCL0316 VLOCL0345 V-LOC* 180 2-0 GRN 23CM GS21 VLOCL0345 VLOCL0436 V-LOC* 180 0 GRN 60CM GS25X12 VLOCL0436 VLOCL0604 V-LOC* 180 3-0 GRN 15CM V20 VLOCL0604 VLOCL0615 V-LOC* 180 2-0 GRN 30CM V20 VLOCL0615 VLOCL0625 V-LOC* 180 2-0 GRN 45CM V20 VLOCL0625 VLOCL0644 V-LOC* 180 3-0 GRN 23CM V20 VLOCL0644 VLOCL0804 V-LOC 180 3-0 GRN 15CM CV23 VLOCL0804 VLOCL2105 V-LOC* 180 2-0 GRN 15CM GS22 VLOCL2105 VLOCL2145 V-LOC* 180 2-0 GRN 23CM GS22 VLOCL2145 VLOCL2246 VLOC180 0 GRN 9 GS-22 VLOCL2246
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- 2026-08-07Open, ClassifiedEquipment maintenance
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- 2026-08-07Open, ClassifiedEquipment maintenance
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- 2026-08-07Open, ClassifiedEquipment maintenance
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
- 2026-07-02Open, ClassifiedLabeling Change Control
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.
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
- 2026-06-01Open, ClassifiedProcess control
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
- 2026-05-29Open, ClassifiedProcess control
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.
Due to customer complaint regarding incorrect display box labeling.
- 2026-05-29Open, ClassifiedUnder Investigation by firm
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Temperature probe devices lack FDA clearance.
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