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NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.

FDAMar 10, 2025Nationwide• Medtronic Xomed, Inc.

Zaarah Rasayan Churan – Elevated Lead (2025)

Products contain elevated levels of Lead (Pb): 88.038 ppm

Class IHigh

FDAMar 10, 2025CA, CT, NJ +1 more• NEW YORK WHOLESALE GROUP

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NIM Vital Nerve Monitor (Medtronic) – stimulus artifact (2025)

Zaarah Rasayan Churan – Elevated Lead (2025)

NovumIQ Syringe Infusion System (Baxter) – Incorrect Installation (2025)

Comprehensive Shoulder Stem (Zimmer) – Surgical Insertion Problem (2025)

Spectral CT on Rails (Philips) – Software Scanning Problems (2025)

Access Vitamin B12 Reagent (Beckman Coulter) – Result Accuracy (2025)

Tandem Mobi Insulin Pump (Tandem Diabetes) – Software Defect (2025)

t:slim X2 Insulin Pump (Tandem Diabetes) – Software Defect (2025)

Checkpoint Guardian Lead (Checkpoint Surgical) – Adhesive Encapsulation Fault (2025)

Rebecca's Bowling Pin Sipper Cup – Lead Poisoning (2025)

CVAC Aspiration System (Calyxo) – Labeling Update (2025)

Avastin Intravitreal Injection (Turbare) – Sterility Concern (2025)

Microstream CO2 Line (Oridion Medical) – Device Usage Risk (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Proxima Drape (Medline) – sterility breach (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)

Proxima Surgical Drape (Medline) – Packaging Sterility Risk (2025)