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
Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.
Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.
Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.
Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.
Biomet, Inc. is recalling specific Vanguard Knee System prosthetic components that are incorrectly labeled with wrong sizes and sides. This labeling error could result in incorrect implant placement during knee replacement surgery.
Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.
Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.
Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.
Medline Industries is recalling 420 units of UNITE FOOT & ANKLE Screws nationwide due to observed intra-operative screw failure when used with specific drill bit sizes. The failure occurs due to excessive torque during surgical insertion.
Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.
Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.
Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.
FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.
The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.
Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia patients.
The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.
Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.
Agfa Healthcare has recalled XERO Viewer imaging software due to a software defect that can cause issues with images. The defect affects approximately 110 units distributed across the US and 19 other countries.
Johnson & Johnson is recalling 384 single-use phacoemulsification packs due to weld defects that may cause surgical delays and corneal swelling during cataract surgery.
Meridian Bioscience is recalling 92 Revogene SARS-CoV-2 test kits due to potential specimen leakage from the cartridge, which could expose laboratory personnel to aerosolized COVID-19 virus.
Teleflex is recalling approximately 497 endotracheal tubes worldwide due to potential failure of pilot balloon inflation or cuff deflation, which could interfere with airway management.
Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.
Align Technology is recalling Invisalign Express 10, Comprehensive, and Moderate systems due to a software defect that may produce incorrect numbers of aligners and incorrect packaging.