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EXALT Model D Duodenoscope (Boston Scientific) – Perforation Risk (2022)

Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

FDAMar 3, 2022Nationwide• Boston Scientific Corporation

Kawasaki W800 (Kawasaki) – Horn Harness Problem (2022)

Kawasaki Motors Corp., U.S.A. (KMC) is recalling certain 2019-2020 EJ800C and 2020-2022 EJ800D motorcycles. The harness securing the vehicle's horn may break due to engine vibration, causing the horn to become inoperable.

NHTSAMar 3, 2022Nationwide• KAWASAKI

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EXALT Model D Duodenoscope (Boston Scientific) – Perforation Risk (2022)

Kawasaki W800 (Kawasaki) – Horn Harness Problem (2022)

Pony.ai Automated Driving System (Pony.ai) – Software Version Risk (2022)

Hyundai Elantra (Hyundai) – Seat Belt Pretensioner Issue (2022)

Freightliner Business Class M2 (Freightliner) – Brake Drum Interference (2022)

Harmony Delivery Catheter System (Medtronic) – Capsule Bond Risk (2022)

Ionic Smartwatch (Fitbit) – Burn Hazard (2022)

PIRANA Descender (Petzl) – Drowning Risk (2022)

Bee Happy Craft Calendar (ALDI) – Lead Paint Violation (2022)

BMW Z4 (BMW) – Engine Cooling System Issue (2022)

Crossroads Sunset (Crossroads) – Electrical Circuit Problem (2022)

Aebi-Schmidt MB3 (Aebi-Schmidt) – Fuel Tube Failure Risk (2022)

Marion Body Works Freightliner M2 (Marion) – Fuel System Risk (2022)

Volvo VN (Volvo) – Cabinet Fastener Issue (2022)

AccessPLUS Hemostasis Valves (Merit) – Guidewire Gap Risk (2022)

FORE-SIGHT ELITE Oximeter Module (Edwards) – Inaccurate Tissue Reading (2022)

FORE-SIGHT ELITE Absolute Oximeter (Edwards) – Inaccurate Tissue Reading (2022)

Pierce Arrow XT (Pierce) – Generator Lifting Cable Problem (2022)

Access-9 Hemostasis Valves (Merit) – Guidewire Gap Risk (2022)

Philips Respironics V60 Ventilator (Respironics) – Electrical Circuit Risk (2022)