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.
Romorgniz 12-Drawer Fabric Dressers sold on Amazon pose tip-over and entrapment risks to children if not anchored to the wall. About 10,040 units are affected.
BMW is recalling certain 2020-2026 S 1000 RR motorcycles because vibration may cause ignition lock failure, leading to engine stalls or electrical system failures.
BCI Foods, Inc. is recalling approximately 4,300 pounds of canned chicken noodle soup that was imported from Canada without the required import reinspection. No illnesses or injuries have been reported.
K&N Engineering is recalling specific K&N and Spectre replacement fuel filters because the O-ring may disintegrate, causing leaks or clogs.
About 670 Sviyatp pool drain covers sold online violate federal safety standards and pose entrapment and drowning hazards. Consumers should stop using affected pools immediately and contact Sviyatp for a refund.
CuddleCubs Creations Baby Highchair Teething Toy Sets are recalled due to pull-string teething toys that violate mandatory toy safety standards. The silicone strings can lodge in a child's throat, creating a risk of choking and respiratory distress.
ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
Argon Medical Devices is recalling One-Piece Introducer Tray kits containing Lidocaine HCL Injection because they do not meet sterility release criteria. The kits were distributed nationwide and internationally.
Abiomed is recalling ABIOMED Insertion Kits due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Nuez Ice Pop bars because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40, which pose a serious health risk to consumers with allergies or sensitivities.
ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3) because in specific scenarios, the pump may fail to decrease the displayed volume and could deliver up to twice the programmed medication amount.
W.Y. Industries, Inc. is recalling WY Duck Sauce packets because the product may contain metal fragments. The recall affects 1,120 cases distributed to New York, New Jersey, Ohio, and Pennsylvania.
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
Abiomed is recalling the Impella CP heart pump set (87,277 units worldwide) due to potential leakage from the introducer sheath that cannot be visually detected by users. The defect affects the 14Fr and 23Fr introducers included in every pump set.
ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.
ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.
Heil is recalling 2025-2026 side loader garbage trucks because water may enter high voltage cabinets, causing electrical shorts, fires, or unexpected shutdowns.
Abiomed is recalling Impella 5.5 SmartAssist S2 heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines that may not be visible to users.
Olympus Corporation of the Americas is recalling the Olympus Ellik Evacuator (Model 194) worldwide because certain sterilization parameters in the instructions may not render the device adequately sterile.
Argon Medical Devices is recalling Transvenous Pacing Electrode Trays with Bipolar Balloon Pacing Electrode 5F because kits containing Lidocaine HCL Injection USP did not meet sterility release criteria.
D'Dioses Fruit Pops, Inc. is recalling D'Dioses Grocella Ice Pop (1 bar, 81.7 g) due to undeclared milk, pecans, pistachios, yellow #5, and red #40. The product was distributed in NJ, CT, NY, and PA.
D'Dioses Fresa Leche ice pops may contain undeclared milk, pecans, pistachios, and food colorings (yellow #5 and red #40). The product was distributed in NJ, CT, NY, and PA.
Argon Medical Devices is recalling General Biopsy Tray kits containing Lidocaine HCL Injection because the kits do not meet sterility release criteria.
Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.
D'Dioses Mango Ice Pops (3.7 oz) are being recalled because they may contain undeclared milk, pecans, pistachios, yellow #5, and red #40. Consumers with allergies or sensitivities to these ingredients should not consume the product.