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.
Turkeyfoot Creek Creamery Chocolate Peanut Butter Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy. All expiration dates are affected.
Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy and wheat. All expiration dates are affected.
Turkeyfoot Creek Creamery Cookie Dough Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy and wheat. All expiration dates are affected.
Ritz Cracker Sandwiches 20 count variety packs are being recalled because of undeclared peanut allergens due to mispackaging. 13,872 cases are affected.
GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.
Bodor i Series laser cutting machines are being recalled because they fail to meet certain applicable federal standards at 21 CFR 1040.10(f)(1) and (f)(2). 20 units are affected.
The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.
Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.
Turkeyfoot Creek Creamery Mocha Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy. All expiration dates are affected.
Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.
The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.
Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.
EMPOWR Acetabular Dual Mobility Poly Bearings are being recalled because of a packaging discrepancy in which incorrect implants were packaged, discovered through a customer complaint. 20 units affected.
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.
GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.
The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.
EMPOWR Acetabular Dual Mobility Poly Bearings, catalog number 952-28-42F, are being recalled because of a packaging discrepancy in which incorrect implants were packaged. 20 units affected.
Medline IV START KIT LAB DRAW-SH convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 184 units affected.
Medline C-SECTION PREP convenience kits are being recalled because they contain BD ChloraPrep Clear 1 mL Applicators that may exhibit an open seal, which may breach sterility. 48 units affected.
Some DIOX-602 portable x-ray systems in use in the United States do not meet the minimum source-to-skin distance requirement of 18 cm. 530 units are affected.
Turkeyfoot Creek Creamery Cacao Artisan Ice Cream in one pint cartons is being recalled because of undeclared soy. All expiration dates are affected.