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Contra Gray Turbo Plus Cups (Young Dental) – Incorrect Cup Type (2023)

one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.

Low

FDAOct 6, 2023IN, MO, TN• Young Dental Manufacturing I, LLC

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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Contra Gray Turbo Plus Cups (Young Dental) – Incorrect Cup Type (2023)

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

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

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

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

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

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

Denture Cleanser (Family Dollar) – Temperature Storage Issue (2023)

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

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

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

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

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

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

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

Dentemp Dental Product (Family Dollar) – Temperature Storage Issue (2023)

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

Acumen IQ Sensor (Edwards Lifesciences) – Flushing Difficulty (2023)

BD Insyte IV Catheter (Becton Dickinson) – Needle Retraction Issue (2023)

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