Cook Medical Llc
400 DANIELS WAY, Bloomington, IN, US
Registered product codes
65 product codes
Recent MDR events
98 on file
- 12 FR COOK SHEATHJul 14, 2026InjuryMW5190684
- WIRE, GUIDE, CATHETERMay 12, 2026InjuryMW5188076
- WIRE, GUIDE, CATHETERMay 12, 2026InjuryMW5188098
- ASCEND SINGLE-USE FLEXIBLE URETEROSCOPEMay 7, 2026Malfunction25111328
- 12 FR COOK SHEATHMar 23, 2026InjuryMW5185640
- MREYEMar 5, 2026Malfunction24518255
- ASCEND SINGLE-USE FLEXIBLE URETEROSCOPEFeb 10, 2026MalfunctionMW5183646
- GUNTHER TULIPDec 2, 2025MalfunctionMW5179698
- COOK PNEUMOTHORAX TRAYOct 6, 2025InjuryMW5176916
- 12FR GUIDING SHEATHSep 29, 2025InjuryMW5176653
Recalls
2 on file
- Open, ClassifiedJan 12, 2024
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
View FDA record ↗ - TerminatedUnknown
A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
View FDA record ↗
Compliance history
Matched by FEI 3005580113.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.