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.
Ascension Orthopedics is recalling specific Radial Head Implants because they were packaged with instructions for a different product.
Edwards Lifesciences is recalling 277 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
Riverpoint Medical is recalling 443 units of 18G Brachy Grids because they are labeled with a CE mark despite not being approved in the European Union.
Sun Pharmaceutical Industries is recalling 5,040 cartons of Loperamide Hydrochloride 2 mg tablets because the carton front and side panels display conflicting caplet counts.
Collagen Matrix Inc is recalling 136 units of Porcine Anorganic Bone Mineral 4.0cc because the product may contain only 2.0cc volume, resulting in mislabeling.
Bound Tree Medical is recalling 747 Curaplex Epi Safe Kits because they are incorrectly labeled with an expiration date of May 2018 instead of May 2019, and the syringe component lacks 510(k) clearance.
Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.
Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.
Ultradent Products, Inc. is recalling specific lots of Enamelast 5% Sodium Fluoride Varnish because the product may have an unpleasant or off flavor.
R&D Systems is recalling 198 Human sTfR ELISA kits because they were packed with the wrong control data card number.
Amerigen Pharmaceuticals is recalling Temozolomide Capsules, 180 mg, due to failed dissolution specifications. The FDA classified this as a Class III recall.
Arcimoto is recalling 2017-2018 FUV motorcycles because they lack required certification labels, which may prevent owners from verifying safety recall status.
Glenmark Pharmaceuticals is recalling 5,016 blister packs of Aprepitant 40 mg capsules because some packs are missing capsules.
CBI Laboratories is recalling 5,363 tubes of Advanced Protection Sunscreen SPF 30 because the product contains less active ingredient than required.
Nidek Inc. is recalling 85 RT-5100 Refractors distributed in Florida because the lens bonding was incomplete.
Zimmer Biomet is correcting the surgical technique for the Compress System to update selection criteria for anti-rotation pin placement.
CBI Laboratories is recalling 2,055 tubes of Options Rx Anti-Oxidant Oil-Free Sunscreen because the product failed to meet specifications for active ingredient percentages.
VistaPharm is recalling Nystatin Oral Suspension because it failed impurity specifications. The affected product is distributed nationwide and in Puerto Rico.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Orange 600 mL bottles due to mold contamination.
Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.
Neomed Inc is recalling NeoConnect Enteral Extension Sets because the sterile pouch labels display an incorrect expiration date of 2016-11-19 instead of 2019-11-09.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil tablets because they were found to be pink instead of the expected cream color.
Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.
Numed Inc is recalling 100 units of Multi-Track Angiographic Catheters because Instructions for Use booklets were not included on the outer pouch.