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.
Synergy Rx is recalling all lots of Reverse DML Lotion because the product lacks assurance of sterility and has CGMP deviations.
Discount School Supply is recalling Environments-brand children's waterproof bibs because the plastic backing can separate, creating a suffocation hazard. No injuries have been reported.
Goulibeur is recalling 240 units of pure butter shortbreads because the packaging fails to identify milk as an allergen source for the butter ingredient.
Volkswagen Group of America is recalling 2017 Audi A3 and S3 vehicles because the air bag control software may deploy the passenger air bag improperly in lower-speed crashes.
Krispy Kreme Doughnut Corporation is recalling Choc Iced Custard Filled Doughnuts because they may contain foreign matter, specifically metal pieces.
Del Monte Fresh Produce is recalling Choice Farms Portabella Mushroom trays due to possible Listeria monocytogenes contamination.
Medtronic is recalling SharkCore LG Fine Needle Biopsy Systems because the handle may break during use.
Sweets & Desserts, Inc. is recalling 384 units of Cheesecake Cherry in Puerto Rico due to undeclared milk and Red #40 food color.
Goulibeur is recalling 200 units of shortbread in Maryland because the packaging lists butter but fails to identify milk as an allergen source.
Synergy Rx is recalling all lots of Jessner's Peel because the product lacks assurance of sterility and has CGMP deviations.
Synergy Rx is recalling Firm and Fade cream because it may not be sterile. The recall covers all lots distributed nationwide.
Philips Medical Systems is recalling 1,218 BrightView XCT nuclear imaging systems worldwide due to four hardware issues, including motion controller failures and door interlock problems.
Del Monte Fresh Produce is recalling Choice Farms Pizza Style Portabella Mushrooms due to possible Listeria monocytogenes contamination.
Medtronic is recalling 1,096 BNX Fine Needle Aspiration Systems because the handle may break during use.
Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.
Synergy Rx is recalling Melatonin 1.5mg Spray because the product lacks assurance of sterility and has CGMP deviations.
CareFusion is recalling 1,200 MaxGuard Extension Sets because of reports of separation and leakage between the Y-connector and tubing.
Synergy Rx is recalling Ultra Lite Cream (Hydroquinone 8%) due to a lack of assurance of sterility and CGMP deviations.
Sweets & Desserts, Inc. is recalling 850 units of Cheesecake Piña (Pineapple) in Puerto Rico due to undeclared milk and food colors Yellow #5 and Yellow #6.
Toshiba American Medical Systems is recalling 254 Ultimax DREX-ULT80 X-ray generators because the system may terminate exposure prematurely during an examination.
Sweets & Desserts, Inc. is recalling Cheesecake Parcha (Passion Fruit) in Puerto Rico due to undeclared milk, food colors, and aspartame.
Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.
Sweets & Desserts, Inc. is recalling Cheesecake Guayaba products due to undeclared milk and food color Red #40. The recall affects 2,000 units distributed in Puerto Rico.
Synergy Rx is recalling Trichloroacetic Acid Solutions in various strengths due to a lack of assurance of sterility and CGMP deviations.
Synergy Rx is recalling Hydroquinone Cream in all strengths due to a lack of assurance of sterility and CGMP deviations.