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.
Bradshaw International is recalling Good Cook Jumbo Roasters because incorrectly finished rims have sharp edges that can cause cuts.
Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.
Siemens Healthcare Diagnostics is recalling Dimension CREA and Dimension Vista CREA tests because they may produce falsely depressed creatinine results in the presence of hemolysis.
Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.
Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.
Elcam Medical is recalling stopcocks because punctured blister packages were found during manufacturing, creating a potential for device contamination.
Intuitive Surgical is recalling 15,834 da Vinci Si Single-Site Crocodile Graspers because the instrument jaws may become fixed in a closed position.
Intuitive Surgical is recalling 13,644 Maryland Bipolar Forceps used with the da Vinci Si Surgical System because the instrument jaws may become fixed in a closed position.
Segway is recalling approximately 17 off-board chargers for its Personal Transporters because a wire can detach and cause an electric shock. No injuries have been reported.
Old World Industries is recalling specific Peak Lithium Rechargeable Jump-Starters because the lithium battery may overheat, increasing the risk of fire.
McNeilus is recalling 2013-2015 concrete mixers and refuse trucks because the installed fire extinguishers may fail to discharge, increasing injury risk during a fire.
Jaguar is recalling one 2016 F-Type vehicle because the power steering system may be in factory operating mode, potentially causing loss of control.
Philips is recalling about 370,000 halogen bulbs because the lens can shatter, posing laceration and burn risks. Consumers should stop using them and contact Philips for a free replacement.
Entegra is recalling 2010 Anthem and 2012-2014 Cornerstone motorhomes because a flexible exhaust tube may tear, allowing hot exhaust to contact other components and increase fire risk.
Juratoys is recalling Sardines and Starfish fishing games because small plastic parts can detach, posing a choking hazard to children.
Cequent is recalling specific Reese Explore Bike Carriers because incorrectly molded cradles may rip and fail, causing bicycles to fall off the rack.
Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Customed, Inc. is recalling 56 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 96 OB Packs CS/4 in Puerto Rico due to inadequate sterilization validation and package integrity.
Wright Medical Technology is recalling 5,687 CrossCHECK Non-Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.
Customed, Inc. is recalling 460 Pery Gyn Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning, despite appearing closed.
Customed, Inc. is recalling 55 plastic surgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 228 PERI GYN PACK CS/6 units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.