Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.

High

FDAAug 24, 2023AL, AZ, CA +39 more• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

AZUR CX 35 Peripheral Coil System (MicroVention) – packaging seal problem (2023)

Peripheral coil system detachable has a potential of unsealed pouch packaging.

Low

FDAAug 24, 2023Nationwide• MICROVENTION INC.

2016 Kia Optima (Kia) – trunk latch failure (2023)

Kia America, Inc. (Kia) is recalling certain 2016-2017 Rio, 2016-2018 Optima, 2017-2018 Optima Hybrid and Optima Plug-in Hybrid vehicles. The trunk latch base may crack, preventing the opening of the trunk from the inside. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 401, "Internal Trunk Release."

High

NHTSAAug 24, 2023Nationwide• KIA

Medical Products Pallets (Inmar) – storage contamination risk (2023)

Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product labeling.

Moderate

FDAAug 24, 2023Nationwide• Inmar Supply Chain Solutions, LLC

Tall Rear Shock (Harley-Davidson) – suspension component issue (2023)

Harley-Davidson Motor Company (Harley-Davidson) is recalling certain Profile Low Rear Suspension and Tall Rear Shocks that were sold as H-D Parts & Accessories with part numbers 54000134 & 54000294. A fastener securing the rear shock absorber may break and allow the rear shock absorber adjuster to damage the rear tire, causing a loss of tire pressure.

High

NHTSAAug 24, 2023Nationwide• HARLEY-DAVIDSON

LA Chopper ABS Kit (LA Chopper) – brake hose problem (2023)

Streamline Industries Incorporated (Streamline) is recalling certain LA Chopper Brake Hose Kits. Please see the attached document for a complete list of part numbers. The hydraulic brake hoses may fail. As such, these brake hoses fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 106, "Brake Hoses."

High

NHTSAAug 24, 2023Nationwide• LA CHOPPER

Kids Bike Helmets (Ecnup) – Head Injury Risk (2023)

This recall involves Ecnup Kids Bike Helmets in size Extra Small (XS), fitting a head circumference of about 18-1/2 to 20-1/2 inches. The helmets are pink, purple, blue, "dinosaur blue" or "aqua ocean world" with red removable padding, black straps and a black buckle. The serial number SL712-202201 and November 2022 are printed on a white label on the inside of the helmet.

High

CPSCAug 24, 2023Nationwide

Elite Pro Pool Vacuum (Compurobot) – Burn and Fire Hazard (2023)

Fire/Burn Risk

This recall involves Aiper Elite Pro cordless robotic pool vacuum cleaners with model number GS100. The Elite Pro unit weighs 11.2 pounds and measures about 15.9 x 14.2 x 10 inches. The dark gray pool vacuum cleaners have the "Aiper" brand name printed on the top/front of the product. The model name and number are printed on the label attached on the bottom side of the pool vacuum.

High

CPSCAug 24, 2023Nationwide• Compurobot Technology Company, of China

Cinchlock SS Anchor Inserter (Stryker) – expired product distribution (2023)

Expired Product distributed

Low

FDAAug 23, 2023Nationwide• Stryker Corporation

LFS Flat Screen Support Arm (DKK Dai-Ichi) – stopper block issue (2023)

The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off.

High

FDAAug 23, 2023MI• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

2017 Bentley Bentayga (Bentley) – fuel module wiring problem (2023)

Fire/Burn Risk

Bentley Motors, Inc. (Bentley) is recalling certain 2017-2023 Bentayga vehicles. The fuel supply module wiring can overheat and melt the flange, resulting in a fuel leak.

High

NHTSAAug 23, 2023Nationwide• BENTLEY

LFS Flat Screen Arm (DKK Dai-Ichi) – stopper block issue (2023)

High

FDAAug 23, 2023MI• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

MINISCAV Vacuum Pump (RA Medical) – documentation inadequacy (2023)

Inadequate documentation of acceptance activity

Low

FDAAug 23, 2023OH• R A Medical Services Holmes House Skipton Road Keighley United Kingdom

Yokohama 504C Tire (Yokohama) – sidewall air leak risk (2023)

Yokohama Tire Corporation (Yokohama) is recalling certain 504C, size 11R22.5 16H tires. A defective belt cushion splice may allow air to leak into sidewall.

High

NHTSAAug 23, 2023Nationwide• YOKOHAMA

2024 Volkswagen Atlas (Volkswagen) – engine bearing issue (2023)

Fire/Burn Risk

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2024 Atlas PA2 and Atlas Cross Sport PA vehicles. The engine connecting rod bearings may become damaged, which can result in engine failure.

High

NHTSAAug 23, 2023Nationwide• VOLKSWAGEN

Reverse Prosthesis Shoulder System (Unknown) – screw size mismatch (2023)

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

Low

FDAAug 22, 2023AZ, FL, IN +11 more

Therascreen KRAS RGQ PCR Kit (Qiagen) – Handbook Revision Issue (2023)

Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid

Moderate

FDAAug 22, 2023Nationwide• Qiagen GmbH Qiagen Str. 1 Hilden Germany

Puritan Bennett Cuff Pressure Manager (Covidien) – power port fixation issue (2023)

Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.

Moderate

FDAAug 22, 2023AL, AZ, CA +13 more• Covidien

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