Hazard
170 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all diagnostic error recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Due to an inventory system error, Clearview Strep A Exact II diagnostic kits were shipped to facilities without the required license to purchase them.
Siemens recalls RAPIDPoint 500 wash/waste cartridges due to manufacturing errors that may cause inaccurate blood test results in clinical laboratories.
Beckman Coulter's Access Vitamin B12 Reagent lot 439850 may produce falsely low or high results, potentially causing misdiagnosis or unnecessary repeat testing.
Philips is recalling 2 Ingenia 1.5T S MRI scanners due to potential alignment errors in the MobiView image review application's cross-reference line functionality, which could affect diagnostic accuracy.
Philips MRI systems may experience alignment errors in the MobiView application's cross-reference line functionality when reviewing images. Nine units have been distributed worldwide.
Philips Ingenia Elition X MRI systems potentially have software alignment errors in the MobiView image analysis application's cross reference line functionality. The recall affects 198 units distributed globally, including 25 in the United States.
Philips recalls the Ingenia 3.0T CX MRI system due to potential alignment errors in the MobiView application's cross reference line function. The 37 affected units are located outside the United States.
Philips SmartPath to dStream medical imaging devices may display alignment errors in cross-reference lines when reviewing images with the MobiView application, potentially affecting diagnostic accuracy.
Philips Ingenia 1.5T MRI systems may display alignment errors in the cross-reference line when reviewing images with the MobiView application, potentially affecting image interpretation.
Philips Evolution Upgrade 3.0T MRI systems may display misaligned cross-reference lines when reviewing images with MobiView. This could compromise diagnostic accuracy.
Philips is recalling Evolution Upgrade 1.5T imaging devices due to potential alignment errors in the MobiView application's cross-reference line functionality. Misalignment could lead to inaccurate diagnostic positioning information.
PhenoMATRIX, an AI-powered bacterial culture interpretation software by Copan WASP, has been recalled because it lacks FDA premarket approval and may provide inaccurate bacterial analysis results.
Siemens Healthcare Diagnostics is recalling the Stratus CS Acute Care cTNI TestPak, a cardiac troponin test, due to increased false positive results that could affect patient diagnosis.
Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.
Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
The Biocartis Idylla INSTRUMENT, an in vitro diagnostic device, has been recalled due to false-positive results in MSI-H testing. These false-positive results could lead to inaccurate diagnoses.
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Hologic is recalling specific lots of the Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay due to potential false positive SARS-CoV-2 results. Users should verify positive results with an alternative testing method.
Hermes Medical Solutions is recalling Hybrid Recon software (versions 4.0.0x and 5.0.0) due to a potential software configuration issue that may cause incorrect alignment during SPECT/CT image reconstruction. The issue affects 778 systems in the U.S. and internationally.
Certain GE Healthcare CT systems may display progressively rotated images, particularly during helical, cine, or cardiac scans. The rotation increases with each image, potentially reaching 56 degrees maximum.
GE Healthcare Revolution Ascend CT systems can produce progressively rotated images during helical, cine, and cardiac scans. Images after the first may be rotated up to 56 degrees, potentially affecting diagnostic accuracy.
GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.
Siemens Atellica CH β2-Microglobulin reagent may produce falsely depressed test results for samples between 18-30 mg/L, potentially leading to missed or delayed kidney disease diagnoses. No illnesses have been reported.
GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.