Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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.
Ultradent is recalling 217 units of Avex CX2 Ceramic Orthodontic Brackets because the design control process was not completed before distribution.
Sandoz Inc. is recalling Bumetanide Tablets USP 0.5 mg because stability testing showed moisture content out of specification.
Alere San Diego, Inc. is recalling 3,621 kits of Cholestech LDX Lipid Profile-GLU test cassettes because an incorrect lot number was printed on the packaging.
3M is recalling specific lots of Unitek Primary Stainless Steel Crowns because LL3 crowns were incorrectly labeled as UR4 crowns.
Valeant Pharmaceuticals is recalling 45,000 tubes of Acanya gel physician samples because they were assigned an incorrect expiration date.
Lin-Zhi International is recalling Norbuprenorphine Level 2 Controls because the analyte degrades, causing decreased concentration readings.
Fresenius Kabi USA, LLC is recalling 71,129 vials of Paclitaxel Injection because the package insert is missing text in the Clinical Studies and Specific Adverse Events sections.
Thermo Fisher Scientific is recalling 914 units of MAS Urinalysis Control Level 1 because the product failed to meet 30-day open vial stability specifications.
Novartis Consumer Health is recalling 11.8 million loratadine 10 mg antihistamine blister packs sold nationwide under seven different store brands because the tablets are chipped or broken.
Synthes USA is recalling 14 Titanium Cannulated Humeral Nails because the packaging incorrectly depicts the device as having 3 distal holes instead of 2.
Hill Dermaceuticals is recalling Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.
Hill Dermaceuticals is recalling specific lots of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.
Anspach Effort is correcting labeling on Pneumatic Systems Operating Manuals to remove unverified claims about cutting biometals, bioplastics, and cement.
Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II because the essential body component is missing from the packaging, rendering the device unusable.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Intact PTH Calibrators because some kits were packaged with only the high calibrator.
Intuitive Surgical is recalling da Vinci Vision System Cart components due to a coating incompatibility that triggers erroneous maintenance alerts.
St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.
Zimmer, Inc. is recalling Versys Beaded Fullcoat Femoral Stems because the packaging bag adheres to the polished device surface.
Dean Foods is recalling one-gallon Fruit Rush Black Cherry fruit drinks due to a potential for premature spoilage. The product was sold in Southern California and Arizona.
Bio-Rad Laboratories is recalling 23 FSE Image Upgrade Kits because of a software issue that affects data export from the EVOLIS analyzer to Laboratory Information Systems.
Dean Foods is recalling Fruit Rush Fruit Punch in Southern California and Arizona because the product may spoil prematurely.
Alere San Diego, Inc. is voluntarily recalling Alere Triage TOX Drug Screen Control 1 because a provided code chip causes the control to fail in QC Sample Mode.
Tolmar Inc. is voluntarily recalling 391,055 bottles of 2% Ketoconazole Shampoo nationwide because the product was found to be subpotent.
Advanced Sterilization Products is recalling STERRAD 200 Sterilizers because they may emit unusual odors into the surrounding environment.
Dean Foods is recalling one-gallon Fruit Rush Lemon Lime fruit drinks sold in Southern California and Arizona due to a potential for premature spoilage.