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.
Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.
Alcon Research LLC is recalling GenTeal Tears Lubricant Eye Gel nationwide due to FDA inspection observations indicating the product may lack assurance of sterility. Consumers should not use affected lots.
Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.
North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.
WHILL, INC. is recalling WHILL Model F powered wheelchairs with software versions before HMI 2.23 and MC 1.05 due to a Bluetooth Low Energy (BLE) communication vulnerability identified through the CISA Vulnerability Disclosure Program.
Scope Health is recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) due to lack of assurance of sterility. The product is distributed nationwide.
Enoki mushrooms distributed by Hemu Trading are being recalled after the product tested positive for Listeria monocytogenes. 1,056 cases are affected.
Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.
Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.
Micro Bird is recalling 2023-2026 G5 and 2024 MB II school buses because a drive belt pulley may damage oil lines, increasing the risk of a fire.
Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.
Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.
Micro Bird is recalling 2023-2025 G5 transit buses because a drive belt pulley may damage oil lines, creating a fire risk.
Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.
Winnebago is recalling 2026-2027 Solis recreational vehicles because the liquid propane hose may be routed over the exhaust heat shield, posing a fire risk.
Grand Design is recalling certain 2025-2026 Lineage recreational vehicles because the driver and passenger seat bases may not have been tightened properly, breaching FMVSS 207.
Stephan Baby Boo Bunnie and Friends toys are recalled after 20 reports of the water-filled cube cracking or breaking, including one case where a child swallowed sharp pieces.
Thermos Stainless King food jars and Sportsman bottles are recalled after 27 reports of stoppers ejecting forcefully on opening, including three consumers with permanent vision loss.
Grand Design is recalling certain 2025-2026 Lineage recreational vehicles because the adhesive securing the roof solar panels may fail, allowing a panel to detach into the roadway.
Honda is recalling model year 2025-2026 CRF250R and CRF450R off-road motorcycles because the handlebar clamp can allow the handlebar to rotate unexpectedly. One crash reported.
Nova Bus is recalling certain 2022-2023 LFS transit buses because a telemetry control unit may cause a data overload, shutting down the unit and causing a loss of drive power.
Medline Industries is recalling multiple convenience kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were distributed nationwide.
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.
B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.