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
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
Invacare power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.
DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.
Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.
Biomeme, Inc. is recalling instructions for the SARS-CoV-2 Real Time RT-PCR Test because shelf-life guidance for resuspended RPC Buffer is incorrect. Instructions specify one week stability, but the buffer is only stable for two days at room temperature.
Tapemark's iontoPATCH On-the-Go patches contain incorrect dosage information printed on the pouch label, though the primary carton label is correct. Approximately 5,141 cartons were distributed nationwide.
Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.
bioMerieux recalled VIDAS Lyme IgG II test devices (two lots) due to a substrate error that prevents tests from running. Users must retest patients, potentially delaying Lyme disease diagnosis.
Forbes Rehab Services is recalling Monoprice charging cables and iClever charging bricks for ProSlate Speech Generation Devices due to fire and electric shock risks if cables are damaged or charging occurs near moisture.
bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.
AMO Manufacturing is recalling Catalys Precision Laser Systems due to a Windows Print Spooler vulnerability that could allow unauthorized remote code execution with system privileges.
bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.
Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.
bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.
bioMerieux is recalling one lot of VIDAS Estradiol II diagnostic test devices due to a substrate error that prevents tests from running, causing delayed results and requiring repeat testing.
Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.
bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.
Karl Storz Udel Sterilization Tray instructions for use have been updated to correct sterilization methods and clarify endoscope compatibility. Ethylene oxide is now excluded as a sterilization modality.
The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.
AMO Manufacturing's iDesign aberrometer systems (711 units, Models G300 and G301) are vulnerable to remote code execution through the Windows Print Spooler service. An attacker could run arbitrary code with SYSTEM privileges to install programs, access or delete data, or create accounts.
bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.
Siemens Healthcare Diagnostics recalled lot 211446 of the Atellica CH β2-Microglobulin assay due to analytical bias in test results. The assay showed positive bias up to 20.9% at some concentrations and negative bias up to 10.5% at others.
Intuitive Surgical recalls 46 da Vinci SP Surgical systems due to software defect causing potential failure or inadvertent delivery of surgical energy. Issue may require surgeon intervention during procedures.