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Amplatzer Steerable Delivery Sheath (Abbott) – Air Embolism Risk (2023)

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

Moderate

FDAJun 12, 2023Nationwide• Abbott

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Cable Issue (2023)

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Moderate

FDAJun 12, 2023Nationwide• Philips North America

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Amplatzer Steerable Delivery Sheath (Abbott) – Air Embolism Risk (2023)

MR 7700 Magnetic Resonance System (Philips) – Smoke Detector Cable Issue (2023)

Sterile Ultrasound Gel (Turkuaz) – Sterility Concern (2023)

SAF-HOLLAND ULX40 (SAF-Holland) – Tire Pressure Management Issue (2023)

DEKA Car Battery (East Penn Manufacturing) – Electrical Connection Issue (2023)

FORD F-450 SD (Ford) – Manual Information Problem (2023)

FORD F-150 LIGHTNING (Ford) – Rear Lightbar Microcrack (2023)

EVIS EXERA III Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

HYUNDAI PALISADE (Hyundai) – Brake Booster Diaphragm Misalignment (2023)

JEEP GRAND CHEROKEE (Jeep) – Engine Crankshaft Defect (2023)

JEEP GRAND CHEROKEE 4XE (Jeep) – Engine Shutdown Risk (2023)

Bronchovideoscope BF Type (Olympus) – Endobronchial Combustion Risk (2023)

Option Elite Retrievable Filter (Argon Medical) – Potential Embolism Risk (2023)

EVIS EXERA Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

EVIS EXERA II Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

Bronchovideoscope (Olympus) – Endobronchial Combustion Risk (2023)

JEEP GRAND CHEROKEE 4XE (Jeep) – Rear Coil Spring Problem (2023)

Narskido Infant Bath Seats (TopGlore) – drowning risk (2023)

ALTEC TG-124S (Altec) – Axle U-bolt Tightening Issue (2023)

Giro Merit Bicycle Helmets – head injury risk (2023)