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.
Exactech is recalling 606 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Halyard Health is recalling specific lots of 15ml saline vials used in the Turbo-Cleaning Closed Suction System because they may leak, potentially exposing contents to infectious agents.
GKI Foods is voluntarily recalling specific lots of Dark Chocolate Coconut Almonds because they may contain an undeclared milk allergen.
Exactech is recalling 643 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Medtronic is recalling MiniMed Silhouette infusion sets because they may over-deliver insulin. The recall covers 1,898,570 units distributed worldwide.
Exactech, Inc. is recalling 306 Optetrak Offset Tibial Trays and Screws because a design incompatibility exists between certain screw sizes and tibial inserts.
GKI Foods is voluntarily recalling Dark Chocolate Strawberries because they may contain an undeclared milk allergen.
Amerisource Health Services is recalling specific lots of Paroxetine tablets because they contain foreign tablets or capsules.
Exactech, Inc. is recalling 411 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
Shoreline Fruit is voluntarily recalling dark chocolate covered cherry products due to undeclared milk in the dark chocolate coating.
GKI Foods is voluntarily recalling Dark Chocolate Pretzel Balls because they may contain an undeclared milk allergen.
Medline Industries is recalling 1,428 Transfer/Gait Belts because the locking mechanism may fail to secure the strap, allowing it to slip through the buckle.
3M is recalling Bair Hugger temperature sensors because a programming error may cause the device to display a temperature lower than the patient's actual body temperature.
GKI Foods is voluntarily recalling Dark Chocolate Pineapple products because they may contain an undeclared milk allergen.
ICU Medical is recalling specific IV administration sets because stopcocks may contain metallic burrs. The recall covers 24,475 units distributed in the US and Thailand.
Exactech, Inc. is recalling 640 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
Medtronic is recalling MiniMed Mio infusion sets because they may over-deliver insulin. The recall covers 1,513,530 units distributed worldwide.
GKI Foods is voluntarily recalling Dark Chocolate Almond Bark products because they may contain an undeclared milk allergen.
Exactech is recalling 678 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain tibial inserts.
Exactech is recalling 889 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Zimmer Biomet is recalling 64 ROSA Surgical Device 2.5.8 units because a software defect may change tool orientation without user command.
Medline Industries is recalling 8,000 units of Sensicare Green Surgical Gloves because a possible open seal on the packaging could compromise sterility.
Medtronic is recalling Sure-T infusion sets because they may deliver too much insulin. This could cause low blood sugar in patients.
Exactech is recalling 920 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
Exactech is recalling 537 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.