2,056 recalls tagged with “cpsc regulated”.
Merit Medical Systems recalled 18,897 custom inflation kits on December 4, 2025. The inflation device handle may detach from the syringe during use, posing a risk of injury. Healthcare providers and patients should stop using the device immediately.
Mobius Imaging recalled 101 units of the AIRO Computed Tomography X-ray system pendant on December 4, 2025. The pendants lack a critical "Safe Hand Position Warning" label, posing a safety risk for healthcare providers. Users should immediately stop using these devices and follow recall instructions.
Mobius Imaging recalled 26 units of the Detachable 10in Pendant Upgrade for the AIRO CT X-ray System on December 4, 2025. The devices lack a critical "Safe Hand Position Warning" label, posing a high risk during operation. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.
Philips North America recalled five Ingenia Elition S MR systems on December 3, 2025. The recall affects systems with software versions R11.1 and R12.1 due to potential errors in stiffness value readings. This issue poses a serious risk to patient safety when interpreting MR Elastography maps.
Philips North America recalled three MR imaging systems on December 3, 2025, due to potential stiffness value errors in exported MR Elastography maps. The systems, identified by product code REF: 781270, have software versions R11.1 and R12.1. Users should stop using the devices immediately and contact their healthcare providers for further instructions.
Philips North America recalled one unit of its Evolution Upgrade 3.0T on December 3, 2025, due to potential stiffness value errors in MR Elastography stiffness maps. The issue affects software versions R11.1 and R12.1. Affected units may misrepresent medical imaging data, posing risks to patient diagnoses.
Philips North America recalled 31 MRI systems on December 3, 2025, due to potential errors in stiffness value readings. The affected models include product codes 781358, 782107, and 782136 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.
Philips North America recalled 9 MR 7700 systems on December 3, 2025, due to potential errors in stiffness maps. The recall affects models with software versions R11.1 and R12.1, posing a high hazard risk. Healthcare providers must stop using these devices immediately and follow manufacturer instructions.
Medtronic Neuromodulation recalled 7,123 units of the Vanta Clinician Programmer Application on December 3, 2025. The software may not function as intended, potentially delaying surgical procedures. Healthcare providers and patients must stop using the software immediately.
Philips North America recalled 24 Ingenia 3.0T MR systems on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed across multiple states and countries. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.
Philips North America recalled Ingenia Ambition S MR systems on December 3, 2025, due to stiffness value errors in exported MR Elastography maps. The recall affects one unit distributed in multiple U.S. states and several countries. Users must stop using the device immediately and follow recall instructions.
Sysco Corporation recalled 17,597 cases of frozen potato product on December 3, 2025. The recall affects Sysco Imperial Potato Tater Barrel due to the presence of clear hard plastic fragments. Consumers should not consume this product and seek refunds immediately.
Philips Healthcare recalled 35 Incisive CT scanners on December 3, 2025. The devices may produce incomplete scans due to an unstable connection inside the floating sensor. Healthcare providers must stop using these devices immediately and follow recall instructions.
McCain Foods USA Inc recalled 21,256 cases of Ore-Ida Tater Tots on December 3, 2025. The recall follows reports of clear hard plastic fragments found in the product. Consumers should not consume the product and should seek refunds or replacements immediately.
CareFusion 303 recalled 2,079 BD Pyxis ES Enterprise Servers on December 3, 2025 due to a software issue affecting timely updates. The recall impacts devices sold worldwide, including the U.S. and Canada. Patients and healthcare providers must stop using the devices immediately.
Philips North America recalled one unit of its MR system on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed worldwide. Healthcare providers should stop using the device immediately and follow the manufacturer's instructions.
Philips North America recalled six MR systems on December 3, 2025. The recall affects devices with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers must stop using the affected units immediately.
Philips North America recalled 21 Ingenia Ambition X MR systems on December 3, 2025, due to potential stiffness value errors. The recall affects models with software versions R11.1 and R12.1, distributed in the U.S. and worldwide. Healthcare providers must stop using these devices immediately and follow provided instructions.
Philips North America recalled 6 MR systems on December 3, 2025, due to the potential for stiffness value errors. These errors can occur when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. Users should stop using the devices immediately and follow recall instructions.
Philips North America recalled 10 Ingenia 1.5T MR systems on December 3, 2025, due to potential stiffness value errors. The affected models include Product Codes 781341 and 781396 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.