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.
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.
Clio LLC is recalling Clio Strawberry Greek Yogurt Bars due to the possible presence of metal fragments. The affected product was distributed nationwide.
Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.
Pear Therapeutics recalls the reSET-O mobile app due to a software defect that allowed patients with positive drug tests to access undeserved rewards. The flaw may undermine substance abuse treatment effectiveness.
Hill Dermaceuticals is recalling DermOtic (fluocinolone acetonide) ear drops due to the potential for broken glass in the glass pipette dropper. The affected product was distributed nationwide.
Exact Medical Manufacturing recalls 78,000 probe covers that lacked FDA premarket clearance. The product was distributed for use in body openings without required 510(k) approval.
The reSET Mobile App had a software defect that incorrectly granted patients access to rewards even with positive drug screens. This undermines the clinical logic of substance abuse treatment.
Exact Medical Manufacturing is recalling 800 units of ultrasound probe covers distributed to six states and Puerto Rico because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.
Clio LLC is recalling Clio Berry Acai flavored Less Sugar Yogurt Bars in Chocolate Coating due to the possible presence of metal fragments. Affected products have best buy dates between April 11, 2021 and June 27, 2021.
Porsche is recalling 2021 Cayenne vehicles because the screw connecting the steering column to the steering box may fail, potentially detaching the steering column and causing loss of vehicle control.
John B. Sanfilippo & Son Inc. is recalling Good & Gather Sweet Cajun Trail Mix because some packages may contain stringy pieces of flexible plastic.
Exact Medical Manufacturing is recalling 12,650 ultrasonic probe covers (Item A-AU-0980N) that were marketed for use in body cavities without FDA 510(k) clearance.
Exact Medical Manufacturing is recalling 100,600 transducer covers distributed across six states because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
Medical Action Industries is recalling novaplus General Purpose Kit (Cat. No. 56603) containing hemostats that may have flaking metal and brown spots on the instruments.
John B. Sanfilippo & Son Inc. is recalling Favorite Day Monster Trail Mix (14 oz, Product Number 04313) because the product may contain stringy pieces of flexible plastic. The recall affects approximately 12,017 cases distributed nationwide.
Clio LLC is recalling Clio Vanilla Greek Yogurt Bars (50g x 10 pack, UPC 861703000106) due to the possible presence of metal fragments. The recall affects 196,863 cases distributed nationwide with best-by dates between February 14, 2021 and June 27, 2021.
Medical Action Industries recalls General Purpose Instrument Trays due to potential flaking metal and brown spots on hemostats. These defects could contaminate surgical instruments.
O'Brien's Own Gourmet Granola in chocolate peanut butter flavor is being recalled because the product contains whey but does not declare milk on the label, posing a risk to consumers with milk allergies.
Exact Medical Manufacturing is recalling 33,250 ultrasonic transducer probe covers lacking required FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Clio LLC is recalling Clio Expresso Greek Yogurt Bars due to the possible presence of metal fragments. The recall affects 6,733 cases distributed nationwide with best-by dates between February 14, 2021 and July 11, 2021.
Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.
EHOB, Inc. is recalling 70 units of the Econocare Plus Waffle Overlay due to trace amounts of dried bodily fluids that may expose patients and healthcare providers to contaminants.
Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.
Viona Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding acceptable daily intake limits.