26 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US), 12mm x 40mm x 75cm (CFN CH12-40-75US)
FDA Recall
Open, Classified
·Product code LIT·September 19, 2024
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.
FDA Recall
Open, Classified
·Hologic, Inc.·Product code LIO·January 8, 2025
TourniKwik Tourniquet Set (CFN 79012)
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code GDJ·May 16, 2024
Enhanced Verify Evaluation Handset (CFN HH90130FA)
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code EZW·April 3, 2025
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
FDA Recall
Open, Classified
·Covidien Llc·Product code QOS·August 19, 2022
InPen App, Model/CFN Number: MMT-8061 (Android Users)
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code NDC·November 13, 2025
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
FDA Recall
Open, Classified
·Medtronic MiniMed, Inc.·Product code NDC·June 16, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
FDA Recall
Open, Classified
·Product code GDW·September 25, 2025
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LGW·December 3, 2025
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
FDA Recall
Open, Classified
·Product code GDW·September 25, 2025
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
FDA Recall
Open, Classified
·Product code GEI·March 5, 2021
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319
FDA Recall
Open, Classified
·Covidien LLC·Product code OLW·July 26, 2018
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·November 21, 2024
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·November 21, 2024
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·November 21, 2024
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
FDA Recall
Open, Classified
·Product code MSD·March 15, 2024
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code LKK·November 21, 2024
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P
FDA Recall
Open, Classified
·Product code MSD·March 15, 2024
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
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CFN·December 15, 2023