Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Luminex Corporation is recalling 4 Verigene Processor SP diagnostic devices that repeatedly failed to produce results, returning No Call outputs instead. Two of three customer complaints involved this malfunction.
Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.
Siemens Healthcare Diagnostics recalls approximately 2,158 units of Atellica CH Lithium_2 reagent (Lot Numbers 110108, 110185, 110238, 110302) due to potential for reagent carryover affecting quality control results, patient samples, and calibrator results.
Siemens Healthcare is recalling Atellica CH Hemoglobin A1c reagent kits due to potential reagent carryover affecting quality control and patient test results. The issue may cause inaccurate diabetes monitoring measurements.
Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.
Abbott Vascular is recalling INDEFLATOR Plus 30 balloon inflators due to increasing complaints of leaks and intermittent loose connections that could affect device function during medical procedures.
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.
Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.
Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.
Medline Industries is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards due to improper storage controls that may affect test result timing. The recall affects 10 boxes distributed to healthcare facilities in six states.
IntraSight Mobile IVUS Systems touch screen modules lack required labeling information including device identifier and manufacturer information. Affected units were distributed to healthcare facilities in the US and internationally.
Hologic is recalling 2,061 Panther Fusion GBS Assay Cartridges because samples at or near the limit of detection may produce false negative results, risking missed diagnosis of group B streptococcus infection.
SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.
Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.
Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.
Philips Healthcare is recalling the StentBoost Live R2.0 application due to a software configuration error. The imaging system fails to stop image acquisition automatically, continuing indefinitely while the pedal is pressed instead of stopping after 40 images.
Ventana Medical Systems has recalled 9,214 BenchMark ULTRA and DISCOVERY ULTRA instruments due to potential fluid leak that could cause electrical short circuit, smoke, and fire.
GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.
Draeger Medical is recalling Babylog VN500 ventilators for neonatal and pediatric patients due to cybersecurity vulnerabilities. The devices are not equipped against potential cyber threats.
DRG International recalls its C-Peptide ELISA kit (Catalog # EIA-1293) after the standards were found to have optical density below the required threshold. The defect may cause invalid test runs and delayed patient results.
GE Healthcare is recalling 55 SIGNA Excite 3T MRI systems due to potential for images to be flipped left to right, which could affect diagnostic accuracy. The affected systems were distributed worldwide.
Shimadzu SonialVision safire X-ray systems may emit radiation exceeding federal limits during some fluoroscopic procedures. The manufacturer is addressing installation criteria to prevent potential dose violations.
Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.
Shimadzu Medical Systems recalls 176 SonialVision G4 X-ray systems that may emit radiation doses exceeding federal standards in some fluoroscopic mode cases. No injuries have been reported.