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
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.
Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.
Cardinal Health is recalling 1,097,048 Monoject 35 mL syringes due to demonstrated compatibility and recognition issues with infusion pumps. The affected units were distributed nationwide.
Cardinal Health is recalling Monoject 6 mL Luer-Lock syringes (approximately 3.9 million units) nationwide due to demonstrated recognition and compatibility issues with syringe infusion pumps.
Cardinal Health recalls 3 million Monoject 12 mL Luer-Lock syringes due to demonstrated compatibility issues with syringe infusion pumps that may affect medication delivery.
The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.
Cardinal Health is recalling 4.9 million Monoject 20 mL Luer-Lock syringes due to compatibility and recognition issues with infusion pumps. Affected lot numbers from 2022 and 2023 were distributed nationwide.
Cardinal Health is recalling 457,200 Monoject 60 mL Luer-Lock tip syringes due to demonstrated compatibility issues with certain infusion pump systems. The affected syringes may fail to function correctly with these pumps.
Cardinal Health recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.
ResMed recalls Astral ventilators due to a battery fault that can cause sudden power loss. The backup alarm system may fail to alert users due to supercapacitor degradation.
B. Braun's Infusomat Large Volume Pump battery pack may sound a false occlusion alarm, causing the device to stop pumping. This interruption of high-risk medications can lead to hemodynamic instability and serious medical consequences.
Smith & Nephew recalled 28 JOURNEY II knee prosthesis inserts because two different articular types were mislabeled and swapped during packaging. The incorrect labeling prevents identification of the actual insert type.
American Contract Systems recalls cardiovascular surgical device components that were subjected to improper ethylene oxide sterilization at excessive temperatures, potentially causing loss of functionality or drug efficacy.
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
Medtronic Sofamor Danek USA Inc is recalling specific batches of Grafton DBM Orthoblend, an orthopedic implant material, because a required sterile packaging inspection step may not have been performed according to specifications.
Two medical device components in the Robotics Pack (I.V. Cath and Adhesive Dermabond) were improperly sterilized and may lose functionality or drug efficacy. Affected units distributed in Florida and Iowa.
Universal Meditech Inc. is recalling diagnostic test strips due to Quality System violations and lack of manufacturing documentation. The company is closing and cannot provide post-market surveillance or support.
FDA is recalling DiagnosUS Ovulation Test Strips from Universal Meditech Inc. because the manufacturer cannot document that the devices were made according to quality standards. The company is ceasing operations and cannot fulfill post-market obligations.
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices in multiple US states.
Centricity PACS-IW medical imaging software versions may store images from two different patients within a single study, creating potential clinical confusion during diagnostic review.