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
The Unsaturated Iron Binding Capacity assay is being recalled because it is not meeting the labeled hemoglobin interference claims stated in its instructions for use. 56,696 units affected.
DASH SARS-CoV-2 & Flu A/B Tests are being recalled because a manufacturing error means the assay may result in a missed diagnosis or delay of treatment through a potential false negative. 710 units affected.
epoc BGEM BUN Test Cards are being recalled because a negative sodium bias may exist in some lots, with an observed average bias of -4.4 mmol/L. 37,554 units are affected.
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.
SafeStar 55 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 9,885,139 units affected.
HME TwinStar HEPA Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 1,019,782 units affected.
The Automated Impella Controller, used with left heart support blood pumps, is being recalled because of a potential issue with the controller not detecting an Impella pump when it is connected. 11,031 units affected.
SafeStar 90 Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's gas sampling port. 669,838 units affected.
Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.
SafeStar 60A Plus bidirectional breathing system filters are being recalled following reports of a slow increase of the CO2 curve when the gas sample is taken from the filter's port. 374,700 units affected.
Ingenia 1.5T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 2,279 units are affected.
Achieva 3.0T MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 460 units are affected.
Philips Allura R8.2.x systems are being recalled because of the potential for temporary loss of imaging (X-ray) functionality due to a software issue. 4,508 units are affected.
Philips is recalling its Intera 3.0T Quasar Dual MRI system due to a potential fire hazard from gradient coil failures. The recall affects one unit distributed worldwide.
Ingenia Ambition S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 611 units are affected.
Inseego USB8 4G Dongle Kits for the Tempus Pro Monitor are being recalled because the kit's USB flash drive contains outdated software that could revert the monitor and reintroduce a previous issue. 55 units affected.
LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.
Blood/MacConkey Biplates, product number R02049, are being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 611 units are affected.
Ingenia 3.0T CX MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 350 units are affected.
LIFEPEARL Drug Elutable Microspheres are being recalled because their actual average diameter is smaller than specification, which may lead to non-targeted embolization. 1,451 units affected.
MR 7700 systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 82 units are affected.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.
SmartPath to dStream for XR and 3.0T systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 294 units affected.
LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.
Strep Selective II Agar, product number R01859, is being recalled because the products may contain surface and subsurface contamination of Listeria monocytogenes. 371 units are affected.