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All product recalls affecting South Dakota.
Includes nationwide recalls (tagged “Nationwide”) and recalls with South Dakota in the distribution area.
Sub-potent Drug; powder discoloration associated with decreased potency
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Sub-potent Drug; powder discoloration associated with decreased potency
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Aston Martin The Americas (Aston Martin) is recalling certain 2021-2024 DBX vehicles. Electrical cables in the battery fuse box may be loose, which can result in an engine stall, or a loss of headlights and/or power steering.
Autocar, LLC (Autocar) is recalling certain 2023 ACX (Xpeditor) and ACTT (Xspotter) vehicles. The steering gear assemblies may have been assembled incorrectly with fewer recirculating balls than are required, which may result in a loss of steering control.
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Forest River Bus, LLC. (Forest River Bus) is recalling certain 2018-2024 Starcraft Allstar, Senator II, 2022-2024 Starcraft Allstar MVP, Senator II MVP, Eldorado National Advantage, 2018 Starcraft Candidate II, 2023 Starcraft Starlite, 2023-2034 Champion Challenger, Elkhart Coach ELKC, and 2019-2024 Glaval Universal transit buses. Unsecured brake lines may be damaged by contact with the frame rail.
Forest River, Inc. (Forest River) is recalling certain 2024 Aurora and Coachmen Catalina Travel Trailers. Improper routing may leave the distribution panel wire unprotected from the battery.