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.
Keystone RV is recalling 2022 Crossroads Zinger travel trailers because the furnace vent extension may not have been installed. A missing vent can allow carbon monoxide to enter the living area.
Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.
DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.
Abbott Molecular recalled Alinity m HBV Application Specification Files due to potential for incorrect high quantitation results on negative samples, which could affect test accuracy for hepatitis B virus detection.
Pfizer is recalling Accuretic (quinapril/hydrochlorothiazide) tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. The impurity resulted from a manufacturing deviation.
Pfizer is recalling Accuretic blood pressure tablets due to manufacturing deviations that resulted in N-nitroso chemical impurities exceeding safe intake limits. Patients should contact their pharmacist or physician.
SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.
Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection nationwide due to deviations from Current Good Manufacturing Practices (CGMP) that raise concerns about product sterility.
Abbott Molecular is recalling the Alinity m HBV AMP Kit due to potential for falsely high results on negative samples. The kits are used for Hepatitis B virus testing in the US and internationally.
Powerade Zero Grape 20oz bottles in 24-variety packs are recalled because they contain undeclared sugar. The product is marketed as zero-sugar, making this labeling error significant for consumers managing sugar intake.
Philips is recalling 331,712 infant and child defibrillator pads worldwide due to potential gel separation from the pad backing. The gel may fold onto itself or separate nearly completely, leaving reduced surface coverage on the pad.
GE Healthcare Revolution Apex and Revolution CT systems display accumulated radiation doses inaccurately high in certain situations. No injuries have been reported.
Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.
Vitae Enim Vitae Scientific is recalling Phenobarbital Sodium Injection nationally due to deviations from manufacturing practices that compromise sterility assurance on this injectable drug.
Sandoz is recalling Orphenadrine Citrate Extended-Release Tablets due to nitrosamine impurity levels exceeding acceptable daily limits. Affected patients should consult their healthcare provider.
Pfizer is recalling 1,104 bottles of quinapril/hydrochlorothiazide tablets due to nitrosamine impurities above acceptable limits. The affected lot (DP3414) was distributed nationwide.
GE Healthcare's 1.5T and 3.0T SIGNA Excite HD MRI systems may display medical images flipped left to right, potentially affecting diagnostic accuracy. The recall involves 76 units distributed worldwide.
Draeger Medical is recalling Evita V500 ventilators due to cybersecurity vulnerabilities that could potentially compromise device functionality. Affected units require software remediation.
Pfizer is recalling 195 bottles of Accuretic blood pressure tablets nationwide due to N-nitroso impurities exceeding acceptable daily intake limits. No illnesses have been reported.
Mylan Pharmaceuticals recalls one lot of Travoprost ophthalmic solution due to subpotency and impurity issues found during stability testing. Patients should consult their pharmacist or physician if they have medication from this lot.
Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.
Garden Highway Southwest recalled 141 units of Asian Style Noodle Salad in Texas due to potential plastic contamination. No illnesses have been reported.
GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.
Maquet Medical Systems is recalling certain Cardiohelp-i Transport Guard units due to a potential loose cylindrical pin that may jam the locking mechanism. This could prevent the device from opening or cause complete disassembly, potentially delaying critical cardiac support.
GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.