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All product recalls affecting Utah.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Utah in the distribution area.
Failed Dissolution Specifications
Microbial Contamination of Non-Sterile Product
Product has been identified as having holes in the packaging.
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Alltrade Tools LLC (Alltrade) is recalling all Kilimanjaro E-bike racks sold at Costco and Costco.com. Please see the recall report for the model numbers and sizes. The connection points may crack, which can cause the rack to fail.
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
Predict+ is being recalled for lack of pre-market clearance/approval.
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.
It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
E-One Incorporated (E-One) is recalling certain 2022-2023 Cyclone 2, 2022-2024 Cyclone N, and Typhoon N vehicles. The engine crossmember may break, allowing the cooling fan to contact the fan shroud and become damaged.
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Altec Industries, Inc. (Altec) is recalling certain 2024 AT and TA series aerial devices, and ST series spray bodies. The fuel or brake lines may not be properly secured, which can cause the lines to become damaged and leak.
This recall involves the plastic dumbbell toy sold with the Fisher-Price Baby Biceps Gift Set. The bar of the dumbbell toy is gray with orange and red plastic weights on each side. The model number GJD49 is located on the back of the kettlebell toy in the gift set.
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series.
Specific lots of product have been manufactured with nonconforming raw materials.