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.
Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.
RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.
Glenmark Pharmaceuticals is recalling 58,368 bottles of Atomoxetine Capsules 100 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. The recall affects bottles distributed nationwide.
The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.
Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.
Medline is recalling respiratory intubation convenience kits because skin barrier components wear out faster than designed. Affected kits may require more frequent replacement than expected.
RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.
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.
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.
Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.
Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.
Wegmans Organic Almonds are being recalled due to an incorrect back label identifying the product as cashews instead of almonds. This mislabeling poses a risk for consumers with tree nut allergies.
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.
RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.
Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.
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.
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.
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.
RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.
THREE RIVERS brand Tutti-Frutti candy contains undeclared FD&C Yellow 5 and Yellow 6 dyes that were not listed on the label. Consumers allergic or sensitive to these colorants should not consume the product.
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.
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.
RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.
Remel, Inc recalls blood agar culture media used in diagnostic laboratories for potential Listeria monocytogenes contamination. The affected lot was distributed nationwide.
Glenmark Pharmaceuticals is recalling 119,040 bottles of Atomoxetine Capsules nationwide due to N-Nitroso Atomoxetine Impurity exceeding FDA recommended limits.