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.
Siemens is recalling Artis zee MP systems because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.
St Jude Medical is releasing new firmware for high voltage implantable cardiac devices to strengthen security against unauthorized access.
Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 3 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.
Siemens Medical Solutions is recalling two Artis Q.zen biplane systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation or patient transfer.
Siemens is recalling 39 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because the C-arm may drop up to 20 mm, potentially injuring patients.
Ion Beam Applications is voluntarily recalling two Proteus 235 Proton Therapy Systems to address a software issue and reduce associated risks.
Siemens Medical Solutions is recalling five Artis Q ceiling units because the display may fail to show an image after exiting power save mode, potentially requiring treatment cancellation.
Four Link Nutriworld is recalling 4-ounce Blueberry Pretzels with a use-by date of 12/01/2018 because the ingredient list failed to disclose milk content.
Philips is recalling specific Ingenuity Core128/Elite X-ray tubes due to a production defect that allows oil leakage, posing a risk to patients and users.
Siemens Medical Solutions is recalling 56 Artis zeego systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
New Seasons Market LLC is recalling Meyer Lemon Chia Muffins because the packaging fails to declare egg as an ingredient.
New Seasons Market LLC is recalling Honey Oat Bran Muffins because the packaging fails to declare egg as an ingredient.
Siemens is recalling 68 Artis zee biplane systems because the large display may remain black after exiting power save mode, potentially requiring treatment cancellation or patient transfer.
Philips is recalling 28 Brilliance Big Bore Radiology systems due to a production defect in the X-ray tube that allows oil leakage, posing a risk to patients and users.
Philips is recalling 28 Ingenuity Core systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.
Cenorin, LLC is recalling 14 HLD Systems 600 Series Washer/Pasteurizers because a supplier quality issue with terminal blocks may cause overheating, charring, or burning.
Philips is recalling 28 Ingenuity TF PET/CT systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.
St Jude Medical is recalling Unify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Zimmer Biomet is recalling 48 Vanguard Complete Knee System tibial bearings because two lots were commingled, creating a risk that 14mm bearings are packaged in 12mm boxes or vice versa.
St Jude Medical is recalling 68,117 Quadra Assura MP implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling 72,673 Quadra Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
St Jude Medical is recalling Unify Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Siemens is recalling Artis zee floor MN systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.
RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software versions 6.0 through 7.0 because dose calculation accuracy may be less than expected in some situations.
St Jude Medical is recalling implantable cardiac devices to release new firmware that strengthens security against unauthorized access.