Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
Growland Inc. is recalling Dried Longan Pulp products due to elevated sulfite levels. The affected product was distributed across seven states.
American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
Prep'd CDA LLC is recalling Chocolate Peanut Butter Protein Balls due to undeclared soy lecithin and undeclared food color additives. Consumers with soy allergies should not consume the product.
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.
American Contract Systems Inc is recalling 1,200 DR DIULUS Injection Pack kits because the manufacturer cannot confirm sterilization assurance requirements were met. This may result in loss of functionality and treatment delays.
Lyons Magnus LLC is recalling Ready Care and Imperial brand vanilla shakes (4 oz) due to potential Listeria monocytogenes contamination. The affected products were distributed to long-term care facilities, skilled nursing homes, and hospitals across the U.S.
Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Keystone RV is recalling certain 2025 Kodiak 2900FKSP and 308BHSL travel trailers because the patio latch screws may loosen, causing the latch to detach during transit.
Daimler Trucks North America is recalling certain 2025–2026 Western Star 47X and 49X and multiple Freightliner models due to a software error that may cause brake lights to fail, increasing crash risk.
Winnebago is recalling 2025 Access and Voyage travel trailers because the tire inflation information on the federal placard is incorrect, which may lead to tire failure.
General Motors is recalling specific 2016-2018 Cadillac and Chevrolet vehicles because the electric power steering assist may fail, increasing crash risk.
Idaho Smokehouse Partners is recalling approximately 29,541 pounds of Chomps Original Beef Stick Mild products due to possible metal contamination. Consumers are advised not to consume the affected items.
International is recalling certain 2025-2026 IC Bus CESB school buses with halogen headlights because activating the high beams turns the low beams off, failing FMVSS 108.
Chrysler is recalling certain 2024-2025 Jeep Wagoneer S electric vehicles because the headlight vertical aim adjustment is not accessible and the horizontal aim is not covered, failing FMVSS 108.
Thor Motor Coach is recalling certain 2023–2026 motorhomes because the slide-out room can extend while the vehicle is moving, increasing crash risk.
Kimpex ski kits for snowmobiles can detach from the vehicle, posing a crash hazard and risk of serious injury. No injuries have been reported to date.