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.
Zydus Chlorpromazine Hydrochloride Tablets, USP, 50 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Boston Scientific UroMax Ultra Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 1,369 units are affected.
TiBrid SA Angled Screwdrivers in 30, 45 and 60 degree sizes are recalled following failure of fusion system instruments in the field. 15 units are affected.
Ultra Violette Velvet Screen SPF 50 mineral sunscreen is recalled nationwide after testing produced inconsistent SPF results ranging from SPF 4 to 64. 49,275 tubes are affected.
Boston Scientific NephroMax Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 458 units are affected.
Zydus Chlorpromazine Hydrochloride Tablets, USP, 25 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
DJO Surgical Altivate Reverse Wedge Glenoid Reamer Boss Drills, 6.5 mm, are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 907 units are affected.
IntelliSpace Cardiovascular software version 8.0.0.4 is recalled because of a software issue that results in the display of outdated information. 4 units are affected.
Reef TA Inserters, part number TA2-001003, are recalled because they may contribute to difficulty disengaging the implant or improper implant positioning, and may carry incorrect UDI-DI marking. 74 units are affected.
Lannett mixed amphetamine salts tablets, 10 mg, lot 25283185A, are recalled because two bottles each contained one 5 mg tablet. 4,848 bottles are affected.
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.
CELSITE BabyPort Set PUR 4.5F IV, catalog 5433742, lot 37041185, is recalled because of the potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. 58 units are affected.
Wasatch Photonics Raman spectrometers are recalled after two potential laser safety failure modes were identified in the product design. The firm states the modes have never been found to occur. 192 units are affected.
Boston Scientific Encore 26 Inflation Devices are recalled because foreign material particles could migrate from the device into a balloon dilatation catheter during use. 39,739 units are affected.
Duloxetine Delayed-Release Capsules, USP, 30 mg, lot 240927C, made for Quallent Pharmaceuticals, are recalled because N-nitroso-duloxetine was above the proposed interim limit. 3,591 bottles are affected.
DJO Surgical Altivate Reverse Wedge Glenoid Reamer Heads are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 927 units are affected.
10Fore Hemostasis Valves are recalled because of a manufacturing issue where the silicone quad ring is deformed or damaged and may cause a foreign body in the fluid pathway. 447 units are affected.
Halyard ENT Packs, model JACK421-04, lot 1647218, are recalled because of the potential for open header bag seals, compromising sterility. 57 units are affected.
Atellica CH Urinary/Cerebrospinal Fluid Protein assay is recalled because of the potential for falsely depressed patient, quality control and calibration results, or delayed results. 11,811 units are affected.
DJO Surgical Altivate Reverse Wedge Glenoid Reamer Sleeves are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 447 units are affected.
Halyard CPT Basic IR Packs, model 1646381, are recalled because of the potential for open header bag seals, compromising sterility. 228 units are affected.
DJO Surgical FA S Altivate Reverse Glenoid Tray kits are recalled across all lots because the reamer may kick or bind up during or immediately prior to use. 439 kits are affected.