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.
GE Healthcare recalls certain Infinia II and related nuclear medicine systems that may have been transported without proper detector support. This risk of detector fall could cause life-threatening bodily injury.
Sklar Instruments recalls ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. Affected units nationwide should not be used.
Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.
A software defect in McKesson Cardiology Hemo's autosave mechanism may cause clinicians to administer incorrect medications. The FDA has issued a Class II recall.
GE Healthcare is recalling Discovery NM/CT nuclear medicine imaging systems that may fail if transported improperly. Unsupported detectors risk mounting mechanism failure and detector fall, potentially causing life-threatening injury.
A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.
Summit Import Corporation is recalling Yu Yee Five Spice Powder due to high levels of lead detected in testing. Consumers should discontinue use and contact a healthcare provider with concerns.
Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.
Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.
Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.
Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The recall affects 512,786 units distributed worldwide.
A software defect in Change Healthcare's Cardiology Hemodynamics software may cause clinicians to administer incorrect medications. The defect affects an autosave mechanism and has been distributed nationwide and internationally.
Intuitive Surgical is recalling 4,259 units of 8MM round tip scissors due to complaints of frayed or broken grip cables. The defect could affect instrument reliability during surgical procedures.
Intuitive Surgical is recalling 1,562 units of 8mm surgical forceps (Model 471048) due to complaints of frayed or broken grip cables. The defect could impair instrument function during use.
Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Endotoxins could pose a risk if contaminated components are used in sterile surgical procedures.
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
Amerisource Health Services LLC is recalling Clobazam 10 mg tablets nationwide due to contamination with foreign tablets or capsules. Patients should contact their pharmacist or healthcare provider.
Hillrom Temperature Management Controller Model 2083516 may experience a power-on self-test error code 'EA POST' during startup. The recall affects 77 units distributed worldwide.
GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening injury.
Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.
NOA Medical Industries is recalling 34 hospital bed side rails (Model 1055050GRY-BOX) because the red button used to engage the rails can break or become stuck, making it difficult to engage the safety rails.
Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.
Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.