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.
Forest River is recalling 2006-2014 Starcraft Prodigy and Quest school buses equipped with specific Ricon wheelchair lifts due to a defect that could cause the platform to fall.
GE Healthcare is recalling 215 Signa HDxt 3.0T MRI scanners because displayed SAR values may be lower than actual head SAR, potentially exceeding safety limits.
Medtronic is recalling Amphirion Deep PTA Balloon Catheters because a potential breach in the pouch seal may compromise the sterilized product.
Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.
Innokas Medical is recalling 424 CARESCAPE VC150 Vital Signs Monitors because the devices may shut down unintentionally without restarting.
The Great Gourmet Inc is recalling Cheesy Crab & Bacon Bites because the labels fail to list wheat, a major allergen.
Tekia is recalling 50 units of Single Piece Hydrophilic Acrylic Intraocular Lenses because they may be labeled with the incorrect diopter power.
The Great Gourmet Inc is recalling specific crab and shrimp cake products because the labels fail to list wheat, a major allergen.
Instrumentation Industries Inc is recalling specific lots of reusable ventilator tubing due to a manufacturing defect that may cause layer delamination and leakage.
Forest River is recalling 2006-2014 Starcraft buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.
The Compounder is recalling specific lots of compounded hormone capsules because an active ingredient was contaminated with penicillin.
The Great Gourmet Inc is recalling three seafood products because their labels fail to list wheat, a major allergen.
WalkMed Infusion is recalling Triton Infusion Pumps because they may fail to detect air in the line when infusing Venofer.
DeRoyal Industries is recalling specific lots of sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during the sterilization process.
Ceterix Orthopedics is recalling 1,364 NovoCut Suture Manager devices because they may cut sutures during knot tensioning, causing knots to unravel.
GE Healthcare is recalling 55 SIGNA Excite 3.0T MR systems because displayed SAR values may be lower than actual head SAR levels during scans.
Synthes is recalling Small Notch Titanium Reconstructive Plate sets because they are being used in spine surgeries, which is a contraindicated use for these trauma products.
Micro Bird is recalling 2006-2014 school buses with Ricon wheelchair lifts where oversized pivot holes may allow bearings to shift, risking platform failure.
DeRoyal Industries is recalling 355 sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during package sterilization.
GE Healthcare is recalling 97 Signa HD 3.0T MRI systems because displayed SAR values may be lower than actual head SAR levels, potentially exceeding safety limits.
Forest River is recalling 2006-2014 Elkhart ECII transit buses because wheelchair lift bearings may move out of position, causing the platform to fall.
The Compounder is recalling Biest TD 86/14 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Stryker is recalling specific lots of Triathlon MIS Modular Distal Capture instruments because they may disassociate during use.
Teleflex Medical is recalling Roesch Flexi-Slip Endotracheal Tube Stylets because the plastic coating may split or break off.
GE Healthcare is recalling 17 SIGNA PET/MR 3.0T scanners because displayed SAR values may be lower than actual levels, potentially exceeding safety limits during head or neck scans.