Class I - Dangerous
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Class I - Dangerous
Cybersecurity vulnerability concerning the software used for sequencing instruments.
ARROW Endurance Extended Dwell Peripheral Catheter System
ARROW INTERNATIONAL
Class I - Dangerous
Potential for catheter separation or leakage
Class I - Dangerous
Cybersecurity vulnerability concerning the software used for sequencing instruments.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Boston Scientific Neuromodulation
Class I - Dangerous
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Merit Medical Systems
Class I - Dangerous
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class I - Dangerous
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Class I - Dangerous
The custom procedure packs contain light handle covers that have been recalled by another firm.