1,823 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
FDA Recall
Open, Classified
·Covidien LLC·Product code GDW·May 17, 2019
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·October 24, 2023
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
FDA Recall
Open, Classified
·InfuTronix LLC·Product code FRN·February 21, 2024
Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
FDA Recall
Open, Classified
·Covidien Llc·Product code GCI·May 12, 2020
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
FDA Recall
Open, Classified
·Covidien Llc·Product code FFT·February 26, 2021
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
FDA Recall
Open, Classified
·Nuclein LLC·Product code QOF·June 25, 2025
Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
FDA Recall
Open, Classified
·Defibtech, LLC·Product code MKJ·October 14, 2024
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105 502-106 - Calf Implant style 1 size 6 UDI-DI code: B490502106 502-201 - Calf Implant style 2 size 1 UDI-DI code: B490502201 502-303 - Calf Implant style 3 size 3 UDI-DI code: B490502303 502-304 - Calf Implant style 3 size 4 UDI-DI code: B490502304
FDA Recall
Open, Classified
·DSAART LLC·Product code MIB·September 26, 2025
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.
FDA Recall
Open, Classified
·Covidien LLC·Product code JOH·April 15, 2026
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
FDA Recall
Open, Classified
·Covidien Llc·Product code QOS·August 19, 2022
SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
FDA Recall
Open, Classified
·Covidien LLC·Product code GDW·May 17, 2019
SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
FDA Recall
Open, Classified
·Covidien LLC·Product code GDW·May 17, 2019
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.
FDA Recall
Open, Classified
·Covidien Llc·Product code FCG·June 26, 2020
CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
FDA Recall
Open, Classified
·CardioQuip, LLC·Product code DWC·May 12, 2021
Permobil TiLite, Models: Aero Z, and ZRA
FDA Recall
Open, Classified
·TiSport, Llc·Product code IOR·September 24, 2021
Pilling Wecksorb Cylindrical Sponges
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code EFQ·September 28, 2022
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780040
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023