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Philips DXR System (Philips) – collimator fall risk (2025)

Potential for collimator to fall as a result of incorrect installation.

FDAMar 10, 2025Nationwide• Philips North America Llc

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.

Moderate

FDAMar 10, 2025Nationwide• Medtronic Xomed, Inc.

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Philips DXR System (Philips) – collimator fall risk (2025)

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

Zaarah Vasaka Powder – Elevated Lead (2025)

Omni-Macs Dietary Supplement (Veridance) – Excessive Iodine (2025)

Zaarah Bhringraj Powder – Heavy Metal Contamination (2025)

Zaarah Gurmar Powder – Elevated Lead (2025)

Zaarah Rasayan Churan – Elevated Lead (2025)

TLX/TLC Implant Driver (Straumann) – depth marking missing (2025)

PDS Plus Suture (Ethicon) – needle curing problem (2025)

PDS II Suture (Ethicon) – needle curing problem (2025)

Ethibond Excel Suture (Ethicon) – needle curing problem (2025)

PROLENE BLU 18IN (Ethicon Endo Surgery) – Manufacturing Curing Issues (2025)

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

Levothyroxine Sodium Tablets (Mylan) – Super-Potent Drug (2025)

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

Cinacalcet Hydrochloride Tablets (Slate Run Pharmaceuticals) – Nitrosamine Impurity (2025)

Sofosbuvir and Velpatasvir (ASEGUA) – Defective Container (2025)

Duloxetine D/R (Direct Rx) – Nitrosamine Impurity (2025)

Sodium Bicarbonate Injection (Exela Pharma) – Sterility Concern (2025)

Hydrogen Peroxide Solution (Consumer Product) – Label Mixup (2025)