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
Red Medical Supplies is recalling EcoGel 100 ultrasound gel due to possible bacterial contamination. Approximately 639 units were sold nationwide through Amazon.com.
Abbott Molecular recalls its Alinity m SARS-CoV-2 Amp Kit (Non-US Assay), an in vitro diagnostic test, due to potential for false positive results. Approximately 11,408 units were distributed worldwide.
Smiths Medical is recalling CBSS-5ML blood sampling system sets due to reported pressure shifts and incorrect pressure readings that may affect the accuracy of blood sample collection.
Customers of Philips HeartStart FRx defibrillators were not notified of previous recalls associated with various defibrillator models. This is a Class II medical device recall.
Smiths Medical ASD Inc. is recalling 870 units of LogiCal blood sampling sets distributed across Europe and Saudi Arabia due to reported pressure shifts and incorrect pressure readings.
Uoc Usa Inc recalls 3 United Orthopedics USTAR II knee components that fail to meet manufacturing specifications for concentricity and dynamic fatigue testing. These defects could affect implant performance.
Inpeco's automation interface module firmware may incorrectly associate laboratory test results with patient sample IDs, potentially causing incorrect patient results.
K2M, Inc. is recalling 23 units of the Chesapeake Anterior Lumbar Removal Tool because units may arrive with missing pins or in disassembled condition. Pins could dislodge during surgery and enter the surgical cavity, requiring intraoperative removal or revision surgery.
Flower Orthopedics Corporation is recalling 33 units of its 2.4mm Drill Bit Kit (Lot 2101321194) because the drill bits lack the AO connect feature, which may delay surgical procedures.
BioMerieux MYLA diagnostic system software versions 4.7–4.8.2 may produce false negative results under certain conditions, potentially missing diagnoses. Affected units are being recalled worldwide.
Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings. Approximately 10,620 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Smiths Medical ASD Inc. is recalling 140 HemoDraw Plus Closed Blood Sampling Sets with LogiCal Pressure Monitoring System for pressure shifts and incorrect pressure readings. Affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.
Smiths Medical LogiCal MEDEX closed blood sampling system sets are recalled due to reported pressure shifts and incorrect pressure readings. Approximately 3,620 units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia.
Elekta medical linear accelerators may have a defective diode that could fail destructively when removed, with risk of ejected debris. No injuries have been reported.
Intuitive Surgical recalled 1,625 Ion Flexison Biopsy Needles due to potential sheath tip separation from the shaft. Affected units are distributed across 29 US states and China; no injuries have been reported.
Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.
The cobas EGFR Mutation Test v2 may produce false positive results for exon 20 insertion mutations, potentially leading to inappropriate treatment. Healthcare providers should verify detected mutations using alternative methods.
Smiths Medical ASD Inc. is recalling approximately 20,800 Antishunt blood sampling sets due to reported pressure shifts and incorrect pressure readings. The affected model was distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.
Elekta Medical Linear Accelerators may experience destructive diode failure with risk of ejected matter. Service personnel could be injured during component removal.
A software defect in the Babylog VN500 Ventilator may cause it to restart, interrupting ventilation and losing PEEP for about 8 seconds. The issue affects 2,169 units distributed nationwide.
W L Gore & Associates is recalling GORE VIABAHN VBX balloon expandable endoprosthesis units due to labeling showing incorrect device dimensions. Two units with specification mismatches were distributed to Italy and Lebanon.
Beckman Coulter is recalling Power Processor 3K laboratory equipment due to a missing splash guard that may expose users to hazardous materials. Approximately 271 units were distributed in the U.S. and internationally.
Smiths Medical ASD Inc. is recalling medex LogiCal 5mL Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect patient safety.
Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.