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
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.
Quest Medical is recalling 17,700 Q2 Multiport Extension Sets distributed in the US and Canada. The nature of the defect is not detailed in available source documentation.
Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.
Coapt LLC is recalling 109 ControlSeal Electrodes due to risk of minor burns or blistering if exposed to direct sunlight or warm temperatures exceeding 12 hours, or if the battery is damaged.
Hillrom Progressa+ hospital beds (499 units) are being recalled due to potential static electricity buildup that could cause mild shock to operators during transport. The affected units were distributed nationwide.
Vasoview 6 Pro endoscopic vessel harvesting systems were packaged in incorrect outer boxes displaying artwork for a different device (Vasoview Hemopro 2). The inner labels and product documentation are correct.
Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.
Smiths Medical recalls a pediatric tracheostomy tube because the outer box shows an incorrect expiration date (3/17/2021) while the actual product has the correct date (3/17/2026). The discrepancy could cause confusion about product validity.
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 recalls approximately 3.1 million Monoject 1 mL Tuberculin Syringes due to demonstrated compatibility and recognition issues with syringe infusion pumps. Nationwide distribution affected.
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.
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.
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.
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.
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.
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.
The Infusomat Large Volume Pump may incorrectly sound an occlusion alarm and stop delivering high-risk medications, potentially causing serious complications.
Universal Meditech Inc. is recalling 40,000 OMTMO ovulation test strips because the manufacturer is closing operations and cannot provide required manufacturing and quality documentation.
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
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.
Universal Meditech Inc. is recalling HealthyWiser UriTest™ UTI Test Strips due to missing documentation of Quality System compliance. The manufacturer is going out of business and cannot fulfill post-market safety obligations.
Diagnostic test strips by Universal Meditech are recalled for unverified performance and manufacturing non-compliance. The firm is going out of business.
Universal Meditech is recalling DiagnosUS hCG pregnancy test cassettes distributed without proper FDA authorization and quality documentation. The company is closing and cannot provide manufacturing records or post-market surveillance data.
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.
Smiths Medical is recalling 31,900 Portex Pro-Vent Arterial Blood Sampling Kits due to missing filter components. Kits without the filter can produce inaccurate test results or expose users to infectious blood.