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.
Indian Motorcycle Company is recalling certain 2022 FTR1200 motorcycles due to fuel tanks with holes that may leak fuel, increasing the risk of fire or injury. Dealers will replace the fuel tank free of charge.
New Cosmos USA recalls about 26,360 DeNova Detect combination natural gas and carbon monoxide alarms because they can enter sleep mode and fail to alert consumers to dangerous gas levels. No injuries have been reported.
Stokke is recalling about 2,890 YOYO³ strollers because the parking brake can disengage unexpectedly. Consumers should stop using them and register for a full refund.
Petidoux is recalling about 620 Celebration Girl's Summer Pajama Sets due to a violation of federal flammability regulations for children's sleepwear. The pajamas pose a risk of burn injuries to children.
Hallmark is recalling about 11,100 Cad Bane Christmas ornaments because mold grew on them when the paint did not fully dry before packaging. The mold poses a respiratory risk. No injuries have been reported.
Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.
MyChai Chai Tea Concentrate Original is recalled nationwide. The FDA found pH levels above 4.1 and missing production records.
Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.
Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.
Baxter Healthcare Corporation is recalling 60,594 units of Regadenoson Injection nationwide due to missing label information on affected lot numbers. Healthcare providers with affected lots should contact the manufacturer for replacement supplies.
Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.
EM Tortillas, LLC is recalling bulk Mexican sweet bread varieties due to undeclared wheat, soy, and egg allergens. Products are packaged in unlabeled poly bags and distributed in California.
GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.
Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.
The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.
DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.
American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.
FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.
Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.
Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.
Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.
DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.
My Chai Inc is recalling MyChai Chai Tea Concentrate KALI nationwide because pH levels were found above 4.1 and production records are missing. Consumers should not consume the product.
Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.
DeRoyal is recalling C-Section Tracepacks containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released.