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
Cardinal Health is recalling Presource ACDF surgical kits for potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses or injuries have been reported.
Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.
HF Acquisition Co LLC is recalling Bio52 and Bio12 HealthFirst Mail In Monitoring Systems (4,021 units) due to a printing error on return envelopes that may cause spore test results to be reported to incorrect customer accounts.
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.
Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.
Stryker is recalling Precision Thin surgical blade attachments that may be out of specification and fail to fit securely into compatible handpieces. The defect affects 238 units distributed worldwide, with no reported injuries.
Microbiologics Inc is recalling HPV verification test panels (REF 8235) due to quality control failures that allowed defective units to be released. The panels may produce invalid test results or fail to detect HPV.
Cardinal Health Presource Kits containing laryngoscopy packs are being recalled due to potential endotoxin contamination in non-sterile surgical strips and patties.
Microbiologics is recalling a lot of HPV diagnostic control materials due to inadequate quality control during release. The control's HPV 16 L1 concentration is too low, potentially causing test failures and invalid results in clinical laboratories.
Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.
Cardinal Health is recalling Presource Robotic Hysterectomy Kits due to potential endotoxin contamination in surgical strips and patties. Endotoxins are bacterial contaminants that could cause complications during surgical procedures.
Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.
CareFusion 303, Inc. is recalling the BD Pyxis MedStation 4000 medication cabinet due to potential drawer and door failures that could delay access to stored medications.
CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.
BD Pyxis MedStation Auxiliary ES medication cabinets are being recalled due to potential drawer and door failures following increased complaints. The failures could delay access to medications stored in the cabinet.
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.
The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.
Philips IntelliVue Patient Monitor MX550 units may fail to generate an alarm when a Hamilton ventilator is disconnected, creating a patient safety risk. The monitor could remain silent without alerting clinical staff.
The IntelliBridge EC10 Module may fail to sound an alarm when a Hamilton ventilator is disconnected. This could allow unnoticed disconnections that could affect patient monitoring.
LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.
Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.
GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.
US Endodontics is recalling endodontic files due to irradiation above specification, which may compromise package integrity. The recall affects 789,729 devices distributed in the US and internationally.
Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.