Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
The Medline EBSI Kit, EBSI1534, is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Med Pride Triple Antibiotic Ointment in 0.9 g packets is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 3,006 tubes affected.
VistaPharm Kerr Insta-Char in an aqueous base, 25 grams activated charcoal, is being recalled because the product did not meet Over-the-Counter Monograph M023.
Rapidol Triple Antibiotic First Aid Ointment, 2 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 84 tubes are affected.
Med Pride 1% Clotrimazole Antifungal Cream, 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 5,755 tubes are affected.
Medline C-Section Kits and Packs are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Port A Cath convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
The Medline Kit: Dressing Change Ped is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive whose butyrate tubing may crack.
Med Pride Bacitracin Zinc Ointment, 500 units in 0.9 g packets, is being recalled because of CGMP deviations observed during an FDA inspection. 1,087 tubes affected.
The Medline Block Tray and Indwelling Nerve Block kit are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
HarmonyAIR A-Series Surgical Lighting Systems are being recalled because of the potential for paint delamination, meaning chipping or peeling, on the light heads. 4,138 units affected.
The Medline Driveline Management Kit and Port Dressing Change Kit are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
ALYON Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 549 units are affected.
Quala Dental Products Topical Anesthetic Gel, 20% benzocaine strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units affected.
VistaPharm Kerr Insta-Char in an aqueous base, 50 grams activated charcoal, is being recalled because the product did not meet Over-the-Counter Monograph M023.
Medline convenience kits including abdominal, bariatric and laparoscopic cholecystectomy packs are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
Medline da Vinci, general robotics and gynaecology laparoscopy convenience kits are being recalled because they contain a recalled lot of Mastisol Liquid Adhesive.
The Medline Labor & Delivery C-Section convenience kit is being recalled because it contains a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Med Pride Triple Antibiotic Ointment in 1 oz tubes is being recalled because of CGMP deviations and deficiencies observed during an FDA inspection. 8,996 tubes are affected.
directCHECK ACT-LR whole blood quality control, level 2, is being recalled because the assayed control carries labeling with an incorrect performance range. 6,060 units affected.
Medline convenience kits including pacemaker, ICD, open heart and pediatric open heart packs are being recalled over a recalled lot of Mastisol Liquid Adhesive.
VistaPharm Kerr Insta-Char activated charcoal in a sorbitol base with cherry flavor is being recalled because the product did not meet the Over-the-Counter Monograph M023.
Medline convenience kits for discectomy, ear, ENT and head and neck procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.
Pearson Quality Topical Anesthetic Gel, 20% benzocaine mint flavor, is being recalled because the product may contain bottles with incomplete seals. 900 units are affected.
PureLife Topical Anesthetic Gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 450 units are affected.