Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
Courage Production, LLC. is recalling ready-to-eat Polish sausage products because they contain undeclared milk (mozzarella cheese), a known allergen.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution because it failed impurity specifications, including an unknown degradant.
SCA Pharmaceuticals is recalling 654 bags of Vasopressin 20 Units in 0.9% Sodium Chloride because the drug was subpotent.
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, or hemorrhage.
Maribel's Sweets, Inc. is recalling Cacao Market Marie Belle New York Dark Chocolate Pearls because the product contains undeclared milk.
Cook Inc. is recalling 383 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Cook Inc. is recalling 631 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.
Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.