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.
P.J. Salvage recalled approximately 9,400 children's pajama sets and robes sold at Nordstrom Rack because they violate federal flammability regulations, posing a risk of burn injuries to children. No injuries have been reported.
Forever 21 recalled about 24,700 children's pajamas sold nationwide from November 2023 through November 2024 due to flammability violations. The pajamas don't meet federal safety standards for children's sleepwear and pose a burn injury risk.
ARVA Neo BT Pro Avalanche Transceivers with defective fuses may lose battery power during use, preventing emergency transmission in avalanche rescues. About 1,067 units sold between September 2022 and January 2025 are affected.
Kichler Lighting has recalled approximately 2,760 Ellerbeck Wall Sconces because electrical wires can become damaged at the adjustable joints, creating a risk of electric shock. No injuries have been reported.
Costway is recalling about 4,400 Babyjoy high chairs due to suffocation and entrapment hazards. The chairs were designed or marketed for infant sleep with excessive incline and have unsafe gaps where children can become trapped.
The Harvard Drug Group is recalling Lorazepam Tablets USP 0.5mg due to sub-potency and failed stability test results. Approximately 82,281 cartons are affected nationwide and in Puerto Rico.
Glenmark Pharmaceuticals is recalling 119,040 bottles of Atomoxetine Capsules nationwide due to N-Nitroso Atomoxetine Impurity exceeding FDA recommended limits.
Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.
Glenmark Pharmaceuticals is recalling 233,040 bottles of Atomoxetine 40 mg capsules nationwide due to N-Nitroso impurity above FDA safety limits. Patients should check their medication bottles and contact their healthcare provider.
RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.
Fagron Compounding Services is recalling 1,330 units of fentanyl Citrate IV bags (Lot C274-000040409) distributed in Pennsylvania due to lack of sterility assurance. The product may pose a contamination risk if administered.
Hollister is recalling AnchorFast Guard endotracheal tube fasteners because decreased skin barrier wear time could cause tube migration. The recall affects multiple lot numbers distributed in the US and Canada.
Physio-Control is recalling 622 LIFEPAK 15 V4 monitors due to a software error that prevents monitoring of carboxyhemoglobin and methemoglobin saturation levels in affected sensors.
RayStation radiation therapy treatment planning software contains an inconsistency in density uncertainty calculations that may affect dose accuracy for proton and light ion treatments. The issue affects systems using HU-to-mass density CT calibration curves from RayStation versions 4.5 through 2024B.
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
Remel's blood agar culture media plates (lot 213971) may contain Listeria monocytogenes contamination visible on the blood side. The affected product was distributed nationwide; users should discontinue use immediately.
Augustine Temperature Management is recalling HotDog return electrode accessory connector cables (Model A136) used with warming blankets and mattresses. Users reported error M-0B-125 indicating improper neutral electrode contact.
Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.
Hollister is recalling AnchorFast Guard Select endotracheal tube fasteners due to decreased skin barrier wear time that could lead to tube migration.
Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.
Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.
Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.
Wabash Valley Farms and Rural King bacon flavored popcorn seasoning products are being recalled because soy allergen is not declared on the label, posing a risk to consumers with soy allergies.
The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.