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.
Interamerican Auto Parts is recalling specific KelvinHID HID bulbs because their light output may be incorrect and blind oncoming traffic, failing federal safety standards.
Kolcraft is recalling inclined sleeper accessories for two bassinet models to prevent infant suffocation. Consumers should stop using the accessory immediately.
Microvention, Inc. is recalling 3,881 units of the Terumo AZUR CX Peripheral Coil System because the devices may be missing the implant coil.
Microvention, Inc. is recalling 445 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.
Fridababy LLC is recalling SmileFrida ToothHugger toothbrushes because repeated chewing may cause the plastic head to break, exposing a small internal metal piece.
Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.
Cardiac Assist, Inc. is recalling 11 TandemLife ECLS Procedure Kits that contained a 29Fr ProtekDuo cannula instead of the intended 24Fr Protek Solo Venous cannula.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 units due to a potential for negatively biased sodium (Na+) urine results.
Volkswagen is recalling 2019 Audi Q7 vehicles because side curtain air bags may not inflate properly in a crash, increasing injury risk.
Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.
MicroVention is recalling 107 units of the AZUR Peripheral Coil System because the implant coil may be missing from the sterile packaging.
Flowonix Medical Inc is recalling Prometra II 40mL implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.
MEDTECH SAS is recalling 39 units of the ROSA One 3.1 Brain Application because cross-sectional images may not display properly, potentially compromising surgery planning.
Zydus Pharmaceuticals is recalling 2,207 vials of Ethacrynate Sodium for Injection due to current Good Manufacturing Practice (cGMP) deviations.
Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.
Arrow International is recalling 343,105 epidural catheterization kits because the included loss of resistance syringes may fail, potentially causing dural puncture.
BMW is recalling 2014-2019 M6 Gran Coupe vehicles because the third brake light may detach, creating a road hazard and reducing visibility for following traffic.
Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.
Respironics is recalling 2,851 V60 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings. This could delay necessary changes, potentially leading to hypercarbia or hypoxemia.
Arrow International is recalling 343,105 epidural catheterization kits because the included syringes may fail, potentially causing dural puncture.
Terumo is recalling 106 Advanced Perfusion System 1 Roller Pumps because the pump shafts may fail, potentially causing the pump to stop during surgery.
BMW is recalling 2020 X6 vehicles because the rear spoiler may detach while driving, creating a road hazard and increasing the risk of a crash.
Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.
Arrow International is recalling 343,105 Epidural Catheterization Kits because the included loss of resistance syringes may fail, potentially causing dural puncture.
Dexcom Inc is recalling the Dexcom G6 CGM App for iOS due to a software defect that may prevent low blood glucose alarms from triggering correctly.