Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. 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.
AudioLineOut is recalling Studio Six Headphone Amplifiers because they pose a risk of serious injury or death from electrocution when used with aftermarket metal base tubes.
YERYORK pressure washers are recalled because they lack a ground-fault circuit-interrupter, posing a risk of shock or electrocution.
Conair is expanding a recall of over 3.6 million Cuisinart grill brushes because metal wire bristles can detach and be swallowed, posing a risk of serious internal injury.
Kmaier recalls infant walkers that violate safety standards by failing to stop at step edges, posing a risk of serious injury or death.
Altec is recalling 2021-2023 Service Body vehicles because water leaks into strobe lights, causing electrical short-circuits that increase fire risk.
BMC Medical is recalling 20,160 Luna G3 APAP devices to report 2024 rework conducted at a warehouse.
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.
American Regent is recalling Multrys (Trace Elements Injection 4) vials due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling 43,460 vials of Nicardipine Hydrochloride Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling specific lots of Cyanocobalamin injections due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling specific lots of Acetylcysteine Solution, USP, 10% due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling Selenious Acid Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
Tobii Dynavox is recalling TD Navio Maxi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
American Regent, Inc. is recalling Cyanocobalamin injections because they contain particulate matter, including hair, glass, and paraformaldehyde.
Shilpa Medicare is recalling 18,434 vials of PEMRYDI RTU (pemetrexed injection) due to reports of green to dark green discoloration in the solution.
Bard Access Systems is recalling BD Needle Kits for Powered Drivers because the obturator may lock to the hub, potentially delaying emergency therapy.
Lidl US is recalling Vitasia Asian Style Wok Spice Mix because a positive test result detected Salmonella in the product.
Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Quinidine Assay because unacceptable precision may cause falsely high results, risking improper patient treatment.
American Regent is recalling 323,000 vials of Tralement (trace elements injection 4) due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.
Tobii Dynavox is recalling TD Navio Midi Speech Generating Devices because damaged battery tabs may cause internal short circuits, heating, and gas venting.
Regeneron is recalling 21,353 vials of Libtayo (cemiplimab-rwlc) injection nationwide due to a lack of assurance of sterility.
Shanghai Ravioli Corporation is recalling approximately 24,900 pounds of frozen, not ready-to-eat Buffalo chicken products produced without federal inspection.
American Regent, Inc. is recalling Aminocaproic Acid Injection due to the presence of particulate matter, including hair, glass, and paraformaldehyde.
American Regent, Inc. is recalling Atropine Sulfate injection vials because they contain particulate matter, including hair, glass, and paraformaldehyde.