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
FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.
Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.
Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.
ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.
Aesculap Inc is recalling disposable trocars with dilating pins (Product Code EK234SU) because their sterile blister packaging may be damaged, potentially compromising sterility. This Class II recall affects units distributed in the US and Canada.
Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.
Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.
Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.
Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.
Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.
Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.
A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.
Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.
Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.
Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.
Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.
Medline Industries is recalling 533 units of gynecological laparoscopy kits and trays manufactured with Nurse Assist irrigation and saline components due to potential lack of sterility. The affected products were distributed nationwide in the U.S. and internationally.
Medline Industries is recalling Wound Care Trays due to potential lack of sterility in solution components. The recall affects 72,624 units distributed nationwide and internationally.
Medline Industries is recalling Centurion LVAD maintenance kits and driveline management trays due to sterility concerns in irrigation solution components from Nurse Assist. The solutions may be non-sterile and could pose infection risks.
Ventec Life Systems recalls VOCSN Patient Breathing Packages because the spiral wrap may detach during ventilation, compromising the breathing circuit and creating a risk of serious injury or death, especially for ventilator-dependent patients.
Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.
Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.
Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.
Medline Industries is recalling tracheostomy care kits and trays due to potential lack of sterility in their component irrigation solutions. The non-sterile solutions pose a risk during patient care procedures.
Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.