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
KWIK-STIK and LYFO DISK quality control kits for culture media are being recalled because affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. 21 units affected.
NeuroSync EYE-SYNC systems containing Pico Neo 2 headsets are being recalled because eye syncing issues render the device inoperable and it cannot be repaired. 27 units are affected.
Medtronic SmartLink Software on the SmartSync Patient Connector is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 3,909 units affected.
Medtronic SmartLink software on the CareLink SmartSync Device Manager is being updated because the system could display an erroneous electrical reset message on interrogation when no reset had occurred. 5,418 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII016A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 6,801 units affected.
The Bravo CF capsule delivery device is being recalled because misapplied adhesive may prevent the pH capsule attaching to the oesophagus or detaching from the delivery device. 128,202 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018A, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 13,240 units affected.
Edwards Optisite OPTI18 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 13,240 units affected.
The Hillrom Q-Link 13 component used with mobile patient lifts is being recalled because it may allow false latching of the quick-release hook. 9,899 units are affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas, model FEMII018AS, are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the cannula body. 558 units affected.
Edwards FEM-FLEX II Femoral Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 847 units affected.
Hillrom LikoScale components used with patient lift adapter kits are being recalled because the Q-link 13 may allow false latching of the quick-release hook. 9,839 units are affected.
Edwards Optisite OPTI16 Arterial Cannulas are being recalled after complaints of a 3 mm to 4 mm section of wire exposed or protruding from the outside of the cannula body. 27,022 units affected.
Infinia, Infinia Hawkeye, Infinia II and Infinia II Hawkeye 4 nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software. 1,822 units affected.
VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.
Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.
Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.
Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.
The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.
Alcon Constellation Vision System Vitrectomy Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 198,205 units affected.
VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
TrueDent Yellow dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 68 units are affected.
TrueDent Magenta dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 94 units are affected.