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
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.
Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.
Medtronic is recalling Vanta Implantable Neurostimulators (Model 977006) because battery life depleted faster than expected, leading to earlier surgical replacements or reprogramming.
Wilson-Cook Medical is recalling specific lots of Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats because they were manufactured with nonconforming raw materials.
Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay during Live or Record mode.
Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.
Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.
Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during Live or Record mode.
Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.
Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.
Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
Medline Industries is recalling 22 Open Heart NIMC Kits because they contain Medtronic DLP Vessel Cannulae that were incorrectly labeled during manufacturing.
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software defect that displays an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay when used with OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.
Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.
Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.
Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.
Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.
3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.
The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.