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Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Potential PCBA leaching from tubing of hemodialysis machines.

FDASep 6, 2023Nationwide• Fresenius Medical Care Holdings, Inc.

2019 Volkswagen Jetta (Volkswagen) – instrument cluster warning (2023)

Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Jetta vehicles. The instrument cluster may not provide an audible warning to let the driver know that the key is still in the ignition when the door is open. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 114, "Theft Protection."

Moderate

NHTSASep 6, 2023Nationwide• VOLKSWAGEN

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Hemodialysis System (Fresenius) – Tubing Leaching (2023)

2019 Volkswagen Jetta (Volkswagen) – instrument cluster warning (2023)

RX Modena Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

RX Daytona Plus Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

AU/DxC Chemistry Transferrin (Beckman Coulter) – stability claims issue (2023)

2008T HD SYS. CDX w/Bibag Bluestar (Fresenius) – PCBA leaching risk (2023)

2008T Hemodialysis System without CDX (Fresenius) – PCBA leaching risk (2023)

Portex Pro-Vent Arterial Blood Sampling Kit (Smiths Medical) – component missing (2023)

MAZOR X Robotic Guidance System (Unknown) – software update (2023)

Buick Envision Seat Cover (Covercraft) – seat cover design issue (2023)

2024 Wilson DWH-750 (Wilson) – tire pressure system problem (2023)

Zimmer Dermatome Blades (Zimmer Surgical) – skin graft quality issue (2023)

Oasis Dry Suction Water Seal Chest Drain (Atrium) – unauthorized reprocessing (2023)

2023 Kenworth T280 (Kenworth) – fuel system fitting issue (2023)

2023 Peterbilt 220 (Peterbilt) – driveshaft break risk (2023)

Guardian System (Angel Medical) – premature service end (2023)

LAVH Pack (American Contract) – component investigation (2023)

Breast Plastics Pack (American Contract) – component investigation (2023)

Ethos Collar Stem 100MM (Onkos Surgical) – Tyvek seal breach (2023)

CVS PCSU SJH Pack (American Contract) – component investigation (2023)