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Admelog (Sanofi-Aventis) – Sterility Seal Issue (2023)

Lack of Assurance of Sterility: Malformed crimped collar seal

FDAApr 11, 2023Nationwide• Sanofi-Aventis U.S. LLC

Henry Schein Chairside Reline Kit (Keystone) - Mislabeling Issue (2023)

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

FDAApr 10, 2023Nationwide• Keystone Industries

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Admelog (Sanofi-Aventis) – Sterility Seal Issue (2023)

Henry Schein Chairside Reline Kit (Keystone) - Mislabeling Issue (2023)

Ortholoc 3Di Fusion Plate (Wright Medical) - Marking Description Error (2023)

Reliance Vision Washer/Disinfector (Steris) - Electrical Component Risk (2023)

Over-Head Ceiling Tube Support (Shimadzu) - Bolt Fastening Issue (2023)

Subaru Ascent (Subaru) - Tire Bead Damage Risk (2023)

Lightning eMotors FT3-86 (Lightning) – Battery Pack Issue (2023)

Super Products Camel (Alamo Group) – Tie Rod Disconnect (2023)

Starcraft Bus Prodigy (Forest River) – Ceiling Panel Problem (2023)

Blue Rhino G2 Tracheostomy Introducer (Cook) – Connection Failure (2023)

Thomas Built SAF-T-LINER C2 Jouley (Thomas Built) - Tie Rod Problem (2023)

Buell 1190 SX (Buell) - Index Spring Installation Issue (2023)

Volvo VNR (Volvo Trucks) – Cruise Control Issue (2023)

Prevost X3-45 VIP (Prevost) – Electrical Grommet Issue (2023)

Ducati Diavel (Ducati) – Foot Peg Breakage (2023)

International TranStar (Navistar) – Wiring Problem (2023)

GMC Savana (GM) – Wiring Incompatibility (2023)

ET III Nano-HA Dental Implant (Hiossen) – Mislabeled Length (2023)

BISSELL Cordless Wet Dry Vacuums (BISSELL) – Fire Risk (2023)

BLÅVINGAD Fishing Games (IKEA) – Choking Hazard (2023)