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VERITAS Infusion Packs (Johnson & Johnson) – Housing Weld Defect (2023)

Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

FDAMay 30, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

VIT-RA-TOX Calphonite #38 (Anatox Inc) – Elevated Lead (2023)

Elevated lead levels

Class IIILow

FDAMay 26, 2023AL, AZ, CA +24 more• Anatox Inc

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VERITAS Infusion Packs (Johnson & Johnson) – Housing Weld Defect (2023)

VIT-RA-TOX Calphonite #38 (Anatox Inc) – Elevated Lead (2023)

Sonne's Detoxificant #7 (Anatox Inc) – Elevated Lead (2023)

Flexiva Pulse 242 TracTip Single-Use Laser Fibers - inten... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse 242 Single-Use Laser Fibers-intended to be ... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse ID-intended to be used as a device that tra... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse ID 242 TracTip single Use Fiber-intended to... (Boston Scientific Corporation) – burn hazard (2023)

Preschool Electric Bicycles – Lead Paint Violation (2023)

Contour next GEN Blood Glucose Monitoring System (Ascensia Diabetes Care US, Inc.) – ascensia diabetes care has determined... (2023)

Aptio Automation SRM (Siemens) – Test Result Firmware Error (2023)

OEC Flexiview 8800 Systems (GE OEC) – Image Intensifier Detachment (2023)

Field Upgrade Kits (GE OEC) – Image Intensifier Detachment (2023)

OEC 9900 Systems (GE OEC) – Image Intensifier Detachment (2023)

OEC 9800 Systems (GE OEC) – Image Intensifier Detachment (2023)

OEC Elite Systems (GE OEC) – Image Intensifier Detachment (2023)

Icelock Ratchet (Ossur) – Mechanical Wear Risk (2023)

Jeep Cherokee (Jeep) – Liftgate Electrical Short (2023)

Ivenix Infusion System (Fresenius Kabi) – Software Defect (2023)

QIAstat-Dx Respiratory Panel (Qiagen) – Error Codes (2023)