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.
Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.
Kohler is recalling about 6,600 automatic transfer switches for generators because they can overheat and cause fires. No injuries have been reported.
Micro-Tech (Nanjing) Co., Ltd. is recalling 40 Trident Endoscopic Ultrasonic Aspiration Needles because they may break in the human body, potentially causing injury.
Riba Foods Inc is recalling Four J Charred Tomato & Basil Sauce because it may contain undeclared soy, wheat, and fish.
Medtronic is recalling Endo GIA Universal stapler kits because a missing sled component may prevent staple formation, risking bleeding or leakage.
Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.
Siemens is recalling 238 SOMATOM Definition Flash CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.
Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
A G Specialty Foods is recalling Zoi Mixed Berry Greek Yogurt Parfaits because coconut is listed in ingredients but missing from the 'Contains' statement.
Southmedic, Inc. is recalling 3,300 sterile disposable scalpels because the product contains non-sterile items labeled as sterile.
Invivo is recalling 4,375 Xper Flex Cardio Physiomonitoring Systems because ventricular end-diastolic pressure readings may be inaccurate. The issue affects specific model numbers used in cardiac catheterization rooms.
Siemens is recalling 91 SOMATOM Force CT scanners due to a software issue that may cause unnecessary radiation exposure.
Bard Peripheral Vascular Inc is recalling 130 units of Seeker Crossing Support Catheters due to potential bacterial endotoxin on packaging hoops, posing a cross-contamination risk.
Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c reagents because the assay may produce erroneously high or low Hemoglobin A1c results.
Forest River is recalling 2017-2019 Vengeance Rouge recreational trailers because they may be missing side marker lights, reducing visibility to other drivers.
Visaris DOO is recalling specific diagnostic X-ray systems due to a potential failure in the tube arm suspension that could cause the arm to descend uncontrollably.
Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and injury.
Nipro Medical Corporation is recalling specific blood tubing sets used in hemodialysis because the heparin line may be occluded.
Kanan Enterprises is recalling Market District Roasted Salted Cashews because the product contains almonds and pecans that are not listed on the label.
Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential raw material cracks that could compromise cleanliness.
Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.
Tosoh Bioscience Inc is recalling HbA1c Calibrators because they may cause erroneous patient test results.