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.
Apollo Care, LLC is recalling specific lots of Semaglutide 9mg vials because they contain nylon and silk-type particulate matter.
Cardinal Health 200, LLC is recalling 52,699 Presource surgical kits because they contain MEDICOM Ritmed Neurological Sponges with unexpected endotoxin variability.
Philips is recalling Azurion Rystem X-ray systems due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.
OBP Medical is recalling ER-Spec Single-Use Vaginal Speculums because a burr on the plastic blade may create a sharp edge, posing a risk of injury to patients and providers.
FDA is recalling V-Loc 180 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that could lead to biocontamination.
Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because bleach concentration may drop below specification, potentially compromising disinfection effectiveness.
FDA is recalling Surgipro sutures due to potential sterile barrier defects that could cause biocontamination and infection.
Bioporto Diagnostics is recalling ProNephro AKI Reagent Kits because a non-validated rework process could lead to missed diagnoses of renal disease.
Cardinal Health is recalling specific Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
BioFire Diagnostics is recalling 2,370 pouches of the BIOFIRE Respiratory Panel 2.1 test due to an increase in false negative results.
Philips is recalling 4,252 Allura Xper FD interventional fluoroscopic x-ray systems worldwide due to a firmware issue that may cause loss of geometry movements.
Avride Inc. is recalling Automated Driving Systems (ADS) with specific software versions that may cause unsafe lane changes or merging without yielding.
Baxter Healthcare is recalling 24,528 units of Duo-Vent Solution Sets due to customer reports of air bubbles in the drip chamber and tubing.
Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.
E-One is recalling specific 2025-2026 fire trucks because a hydraulic valve defect may prevent outriggers from extending or retracting, potentially delaying emergency response.
Covidien, LP is recalling V-Loc 90 Absorbable Wound Closure Devices due to potential sterile barrier packaging defects that may cause biocontamination.
Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.
Philips is recalling 2,016 Azurion interventional fluoroscopic x-ray systems worldwide due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.
Medline Industries is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness.
SHEANDRO LLC is recalling Vodka Tomato Sauce because the label declares cream and cheese but fails to declare milk, a major allergen.
BD Switzerland is recalling 93,700 intravascular extension sets because they may not have received adequate sterilization processing.
Medline is recalling Micro-Kill Bleach Germicidal Wipes because reduced bleach concentration may compromise disinfection effectiveness, potentially allowing pathogenic microorganisms to survive.
Cardinal Health is recalling Presource Kits containing MEDICOM Ritmed Neurological Sponges due to unexpected variability in endotoxin levels.
Halcore Group is recalling 2025-2026 Horton ambulances because touchscreen failures may prevent emergency lights from activating, increasing crash risk.
Chrysler is recalling 81 2026 Jeep Grand Cherokee and Grand Cherokee L vehicles because a software issue may cause windshield wipers to fail, reducing visibility.