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.
St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.
Medical Depot is recalling the Nitro Glide Knee Walker (model 791RD) because the tiller can separate from the base assembly, potentially causing users to fall. The recall affects 667 units distributed nationwide and in Canada.
B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.
B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.
Snapchill, LLC is recalling approximately 549,146 cans of Black Coffee + Chocolate Syrup canned beverages marketed under Bold Bean Coffee Roasters and Larry's Coffee brands due to potential under-processing that may allow pathogenic growth.
B. Braun Infusomat SPACE IV pump sets may experience backcheck valve malfunction, causing medication backflow between containers and preventing proper IV line priming. This could result in adverse drug reactions, incorrect medication doses, or medication loss.
Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.
Hologic Inc. is recalling 2,642 Horizon X-Ray Bone Densitometer units due to non-conformance with electromagnetic compatibility safety standards. The devices exceeded acceptable limits per international technical standard IEC 60601-1-2.
Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.
B. Braun is recalling Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY (Model 362420) IV infusion sets due to backcheck valve malfunction that can cause medication to flow backward from secondary to primary IV containers.
B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.
Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.
Surgical image guidance software in NGENUITY 3D systems may miscalculate lens axis placement during eye rotation, potentially causing astigmatic error and decreased visual acuity.
Glenmark Pharmaceuticals is recalling Pravastatin Sodium 80mg tablets nationwide due to failed dissolution specifications. The affected tablets may not dissolve properly, potentially affecting drug absorption.
Fresenius is recalling DELFLEX dialysis solution due to tube weld failures causing slow leaks that are difficult to detect. 183 cases affected nationwide.
Snapchill, LLC is recalling 549,146 cans of Black Coffee + Sugar beverages under the brands Bold Bean Coffee Roasters and Kahawa 1893 Coffee Inc. due to potential under-processing during manufacturing.
Snapchill, LLC is recalling Fire Grounds Coffee Co. Vanilla Nito canned beverages due to potential under-processing. Approximately 549,146 cans were distributed nationwide in the United States and Canada.
Dandelion Chocolate is recalling 372 units of chocolate-covered cocoa nibs from California and Nevada due to undeclared hazelnuts. Consumers with hazelnut allergies risk allergic reaction.
Snapchill, LLC is recalling Larry's Coffee Nitro Sweet(ish) canned beverages due to potential under-processing. The recall affects 549,146 cans distributed nationwide and in Canada, with expiration dates between June 16, 2024 and April 16, 2025.
Starter Bakery is recalling Multigrain Sourdough Bread (UPC 8 50025 60902 9) distributed in California because sesame seeds are listed in ingredients but not declared in the allergen warning. People with sesame allergies may unknowingly purchase this product.
BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.
Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.
B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.
Snapchill is recalling 549,146 cans of Heine Brothers Coffee Toasted Coconut for potential under-processing. Products were distributed nationwide and in Canada with expiration dates from June 2024 through April 2025.
Infusomat SPACE IV infusion sets are recalled due to a backcheck valve defect that may cause medication to flow backward into primary IV bags, potentially resulting in medication loss or adverse drug reactions.