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All product recalls affecting Iowa.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Iowa in the distribution area.
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.
Nova Bus (US) Inc. (Nova Bus) is recalling certain 2022-2023 LFS transit buses. The engine wiring harness may be the incorrect length, which can result in harness damage and a loss of drive power.
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
A cybersecurity vulnerability was discovered through internal testing.
Vials of implant bone granules may contain less product then specified on labeling.
A cybersecurity vulnerability was discovered through internal testing.
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
Potential for microbial contamination.
Forest River, Inc. (Forest River) is recalling certain 2025 Coachmen Apex and Remote travel trailers. The solar panel wiring may be incorrectly wired to the battery, causing it to melt.
Potential for microbial contamination.
Preset treatment parameters are not consistently being used in accordance with the IFU.
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Autocar, LLC (Autocar) is recalling certain 2020-2026 DC (Legend) vehicles. The incorrect blower motor fuse may have been installed.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
Nova Bus (US) Inc. (Nova Bus) is recalling certain 2022-2023 Nova Bus LFS transit buses. The high voltage batteries may have loose hardware that can fall inside the battery pack and create a short circuit.
Shyft Group (Shyft) is recalling certain Blue Arc BA4L-800 vehicles equipped with Aries LFP battery packs. The battery pack may be improperly sealed and allow liquid to enter the battery.
Starcraft RV (Starcraft) is recalling certain 2025 Autumn Ridge travel trailers. The installed safety chains are rated at 7,600 lbs. and the actual Gross Vehicle Weight Rating (GVWR) is 7,995 lbs. This can cause the chains to fail, allowing the tow vehicle to separate from the trailer.