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 the agency’s own highest classification or reported deaths or serious injuries, 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
Biomet is recalling 136 units of the Outer Sheath 4.5/5.0,6.5 because the device and tray failed steam sterilization validation testing.
Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the cardiac valvular apparatus during use.
Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because they can become entrapped in the heart's valves during use.
Medtronic is recalling 177 Mazor X Surgical System Positioner Type II units because they may unexpectedly detach from the operating table, posing a risk of blunt injury to patients.
RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.
Endologix is recalling Ovation iX Abdominal Stent Graft Systems because a material weakness may cause polymer leaks during implantation, potentially leading to clinical events.
Genicon, Inc. is recalling Natura Model 210-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
RaySearch Laboratories is recalling RayStation 8B Service Pack 2 software due to a defect in dose calculation algorithms that could underestimate radiation dose.
RaySearch Laboratories is recalling RayStation 5 Service Pack 3 software due to a dose calculation error that may underestimate radiation dose.
Canon Medical System is recalling 24 Infinix-8000C digital radiography systems because loose bolts may cause the catheterization table to tilt.
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.
Genicon, Inc. is recalling Natura Model 210-005-052 trocars because the plastic optical tip may detach from the metal shaft.
Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.
Arrow International is recalling FlexTip Plus Epidural Kits because a rotatable collar on the filter may detach, causing a leak.
Genicon, Inc. is recalling Natura Model 210-005-151 cannulas because the plastic optical tip may detach from the metal shaft.
Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.
Genicon, Inc. is recalling GENILook Model 200-005-153 laparoscopic scopes because the plastic optical tip may detach from the metal shaft.
Genicon, Inc. is recalling GENILook Model 200-105-152 devices because the plastic optical tip may detach from the metal shaft.
BioFire Diagnostics is recalling the FilmArray BCID Panel due to an increased risk of false positive Proteus results when used with specific blood culture media.
Intuitive Surgical is recalling IS4000 stainless steel reprocessing trays because small holes in the sterilization wrap could compromise sterility and increase infection risk.
Genicon, Inc. is recalling GENILook cannulas because the plastic optical tip may detach from the metal shaft. The recall affects 378 boxes distributed in the US and abroad.
RaySearch Laboratories is recalling RayStation 8B Service Pack 1 due to a software error that could underestimate radiation dose.
Elekta, Inc. is recalling 32 Unity image-guided radiation therapy systems due to a potential risk of Legionella presence in the machine room heat exchanger condensation collection tray.
Smith & Nephew is recalling 58 R3 Acetabular Shells because a manufacturing error resulted in out-of-specification devices.
Smith & Nephew is recalling 1,766 R3 Multi Hole Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.