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.
Play and Park Structures is recalling about 150 SuperMax Triple Slides because a gap between the rails near the entrance poses an entrapment hazard to young children. No injuries have been reported.
TP Orthodontics is recalling 126 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.
NatureBox is recalling specific lots of Whole Wheat Chocolate Animal Cookies because they may contain undeclared soy lecithin.
DePuy Mitek is recalling 84 units of the Latarjet EXPERIENCE Sharp Curved Ostetome due to reports of the product loosening or coming unscrewed from the handle.
Synthes (USA) Products LLC is recalling 235 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
Zimmer Biomet is recalling 54 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Zimmer Biomet is recalling 53 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may have compromised the sterile barrier, potentially leading to infection.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Kroger Specialty Pharmacy is recalling one lot of Ondansetron 8 mg tablets because the product lacked required processing controls.
Kroger Specialty Pharmacy is recalling Revlimid 20 mg oral capsules because of a lack of processing controls. The recall affects specific lots distributed in MS, LA, AR, IL, and FL.
TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Boston Scientific is voluntarily recalling 34 Pinnacle Anterior Apical pelvic floor repair kits due to a Class II safety concern. The devices were distributed worldwide.
Datascope is recalling four custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.
Sugarfina LLC is recalling Platinum Bling Rings because an internal audit found undeclared fish gelatin. The product was distributed in 16 states.
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.
Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.
Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.