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Da Vinci Needle Driver (Intuitive Surgical) – Needle Dislodge Risk (2023)

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

High

FDAOct 6, 2023CA, CO, FL +11 more• Intuitive Surgical, Inc.

CereLink ICP Extension Cable (Integra) – Expanded Recall (2023)

Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.

Moderate

FDAOct 5, 2023Nationwide• Integra LifeSciences Corp.

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Da Vinci Needle Driver (Intuitive Surgical) – Needle Dislodge Risk (2023)

CereLink ICP Extension Cable (Integra) – Expanded Recall (2023)

CareFusion Medication System (CareFusion) – Dispensing Error Risk (2023)

Mobilett Mira X-Ray (Siemens) – Buzzer Mounting Issue (2023)

TruWave Pressure Monitoring Set (Edwards Lifesciences) – Flushing Difficulty (2023)

Veradius Unity C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Marijuana Test Strip (Family Dollar) – Temperature Storage Issue (2023)

First Response Pregnancy Test (Family Dollar) – Temperature Storage Issue (2023)

Azurion IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

FloTrac Sensor (Edwards Lifesciences) – Flushing Difficulty (2023)

BV Endura Surgery Systems (Philips) – Puerto Rico Delivery Issue (2023)

FloTrac Sensor with VAMP (Edwards Lifesciences) – Flushing Difficulty (2023)

Integris-Allura IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

Clearblue Pregnancy Test (Family Dollar) – Temperature Storage Issue (2023)

Hillrom Progressa+ Bed (Baxter) – Static Electricity Risk (2023)

Blood Uric Acid Monitoring System (Visgeneer) – Unapproved Distribution (2023)

Oral B Mouth Sore Rinse (Family Dollar) – Temperature Storage Issue (2023)

Teeth Whitening Pen (Family Dollar) – Temperature Storage Issue (2023)

CardioMEMS Patient System (St. Jude Medical) – Power Connector Risk (2023)

Fixodent Adhesive (Family Dollar) – Temperature Storage Issue (2023)