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.
National Food & Beverage is recalling Razzoo's Creole Sauce in Texas due to undeclared codfish powder, a potential allergen hazard.
Centurion Medical Products Corporation is recalling various LVAD kits because incomplete seals on the sterile package may compromise sterility.
Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
B. Braun Medical is recalling 3,300 units of Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
National Food & Beverage, Inc. is recalling Razzoo's Gumbo Base in Texas due to undeclared codfish powder, a potential allergen hazard.
Datascope is recalling specific lots of Reinforced Introducer Sets due to potential sterility compromise in breached pouches.
Lumitex is recalling Giraffe Blue Spot PT Lite Phototherapy Systems because some units may have light output below the recommended minimum.
Centurion Medical Products Corporation is recalling specific umbilical trays because incomplete seals on the sterile package may compromise sterility.
B. Braun Medical is recalling 19,500 Safeline Y-Type Blood Sets due to a potential for leakage at the joint between the blood filters and tubing.
Roche Diabetes Care is recalling Accu-Chek Aviva Plus test strips because they may fail to dose, potentially delaying treatment decisions.
Stryker is recalling Telescopic Smoke Evac Pencils because hairline fractures could cause electrical current to arc, potentially burning patients or users.
Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling RoyalSilk XLARGE gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Cardinal Health is recalling AAMI 3 fabric surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Centurion Medical Products Corporation is recalling various laceration and medical trays due to incomplete seals on sterile packages that may compromise sterility.
Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Biomerieux Inc is recalling 738 VIDAS 3 immunoanalyzers because a software defect may allow expired calibrations to be used without warning, potentially causing false test results.
Cardinal Health is recalling specific lots of AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Centurion Medical Products Corporation is recalling various pelvic exam trays because incomplete seals on the sterile packages may compromise sterility.
Centurion Medical Products is recalling 270 irrigation kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.
Centurion Medical Products is recalling specific sterile medical kits because incomplete seals may compromise sterility.
Cardinal Health is recalling Genius 2 Tympanic Thermometers because calibration frequency may not ensure readings remain within the stated accuracy range.
Centurion Medical Products Corporation is recalling 350 ultrasound guided PIV kits due to incomplete sterile package seals that may compromise sterility.
Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
Dexcom Inc is recalling 112,415 G5 Mobile Receivers due to software issues that may prevent patients from receiving glucose values or alerts.