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
Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.
MEDITECH Expanse Laboratory modules are recalled because entering multiple keys that trigger input simultaneously may remove data from the first field of screens or questionnaires. 148 units are affected.
VITROS Chemistry Products LAC Slides from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,908 units are affected.
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.
Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.
VITROS Chemistry Products LAC Slides, catalog 8150112, from coating 0130 and above are recalled because of increased calibration failures on VITROS XT systems, delaying lactate results. 2,320 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 10,960 units are affected.
Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.
Frontier Devices 14 mm Distraction Pins in 5 single packs are recalled because the labeling includes a shelf life that has not been validated. 2,700 units are affected.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
Frontier Devices 16 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 490 units are affected.
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
Frontier Devices 14 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated.
ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.
DJO Surgical Altivate Reverse Wedge Glenoid Reamer Sleeves are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 447 units are affected.
Boston Scientific Encore 26 Inflation Devices are recalled because foreign material particles could migrate from the device into a balloon dilatation catheter during use. 39,739 units are affected.
DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.
TiBrid SA Angled Punch Awls in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
Halyard CPT Basic IR Packs, model 1646381, are recalled because of the potential for open header bag seals, compromising sterility. 228 units are affected.
LinkSymphoKnee modular TiNbN tibial components, size 5, REF 880-100/50, are recalled because some were manufactured with two uncoated security screws. 8 units are affected.
10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.
Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.
Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.
Boston Scientific UroMax Ultra Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 1,369 units are affected.