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.
BlueStar Direct LLC is recalling 50 lb. bags of dry dates due to undeclared sulfur dioxide. The product was distributed to one location in Illinois.
Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.
Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.
Smiths Medical is recalling 1,000 units of medex TranStar DPT pressure transducers that may monitor inaccurately or interrupt monitoring due to a manufacturing defect. Users may be unable to zero the device.
Ad-Tech is recalling Spencer Probe Depth Electrodes due to an incorrect MRI safety label. The device was incorrectly labeled as MR Conditional when it is actually MR Unsafe and not cleared for MRI use.
Smiths Medical is recalling the medex TranStar 72-inch Double Monitoring Kit due to a manufacturing defect in the pressure transducer that may cause inaccurate pressure readings or monitoring interruptions. Approximately 6,590 units have been distributed worldwide.
Smiths Medical recalls the medex TranStar Patient Mount Monitoring Kit (1,740 units) due to manufacturing defects that may cause inaccurate or interrupted pressure monitoring.
Smiths Medical ASD is recalling the medex TRANSTAR MONITORING KIT due to a manufacturing defect that may cause inaccurate pressure readings, monitoring interruption, or inability to zero the device. Affected units have Lot Number 4270117.
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
Medtronic Neuromodulation is recalling the SynchroMed II Infusion Pump (Product Number 8637-20) due to potential data corruption in the pump's memory that could prevent proper interrogation of the device.
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
Medline is recalling certain Centurion tracheostomy kits due to potential non-sterility if the packaging seal is compromised. The affected kits may allow non-sterile product use.
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
Smiths Medical is recalling 1,640 units of medex TranStar pressure monitoring sets due to manufacturing defects in the pressure transducer that can cause inaccurate pressure readings or monitoring interruptions.
Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Medtronic Percept RC implantable neurostimulators (Model B35300) may fail to communicate with the A610 DBS Clinician Programmer, displaying an 'Invalid Device' message. This prevents clinicians from adjusting therapy.
Salt City Baking Company recalls Sour Charlie bread due to missing ingredient labeling. Product contains wheat flour but was distributed without an Ingredients Statement, posing a risk to wheat-allergic consumers.
Smiths Medical is recalling certain CADD Medication Cassette Reservoirs due to a weakened weld joint between the medication bag and tubing, which could result in medication leakage. No injuries have been reported.
Smiths Medical is recalling 1110 units of the medex TranStar DPT pressure transducer due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip failure within the device.
SureLife Foods Paleo Bars labeled as gluten-free contain gluten above 20 ppm according to consumer advocacy group testing. Approximately 48,384 units were distributed in California and Oregon.
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
B-K Medical A/S is recalling 1,648 ultrasound systems due to loose power connections that can cause excessive heat and potential thermal events.
Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.
Smiths Medical is recalling the medex TranStar Pressure Transducer Kit due to manufacturing defects that may cause inaccurate pressure monitoring or inability to zero the device.