Covidien LLC
225 recalls on record · Latest: Jun 19, 2024
FDA Devices Moderate Jun 19, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
FDA Devices Moderate Aug 9, 2023
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
FDA Devices Moderate Jan 18, 2023
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
FDA Devices Critical Jul 13, 2022
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
FDA Devices Critical Jul 13, 2022
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Devices Critical Jul 13, 2022
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Devices Critical Jul 13, 2022
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Devices Critical Jul 13, 2022
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Devices Moderate Feb 9, 2022
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbe…
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
FDA Devices Moderate Dec 15, 2021
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progre…
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
FDA Devices Critical Dec 15, 2021
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
FDA Devices Moderate Apr 21, 2021
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applicati…
FDA Devices Moderate Apr 7, 2021
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric r…
FDA Devices Moderate Apr 7, 2021
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric …
FDA Devices Moderate Mar 3, 2021
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias via laparosco…
FDA Devices Moderate Jan 6, 2021
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic sur…
FDA Devices Moderate Jan 6, 2021
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical…
FDA Devices Moderate Nov 18, 2020
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require res…
FDA Devices Moderate Aug 12, 2020
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.…
FDA Devices Moderate Jun 10, 2020
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for…
FDA Devices Moderate Jun 10, 2020
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surg…
FDA Devices Moderate Jun 10, 2020
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surg…
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage…
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected…
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Samp…
FDA Devices Moderate May 20, 2020
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sam…
FDA Devices Moderate May 20, 2020
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage …
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage …
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simult…
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and…
FDA Devices Moderate Mar 11, 2020
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits…
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation…
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or liga…
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation an…
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation …
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation …
FDA Devices Moderate Feb 26, 2020
Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
FDA Devices Moderate Feb 26, 2020
Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation a…
FDA Devices Moderate Feb 26, 2020