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.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
PepsiCo is recalling specific 12 fl. oz. Diet Pepsi cans because the outer case lists Aspartame while the individual can wrap states the product is Aspartame free.
Siemens Healthcare Diagnostics is recalling 449 syngo Lab Data Manager systems due to software issues. The recall covers systems distributed in the US and nine other countries.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Philips is recalling two Brilliance iCT CT scanners because a component may fail, causing image artifacts. The devices were distributed only to China and the UK.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved when it is non-valved.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels and instructions for use list an incorrect metallic coating material symbol.
Integra LifeSciences Corp. is recalling Talar Dome Total Ankle Prostheses because the labels list an incorrect metallic coating material symbol.
Ethicon, Inc. is recalling VICRYL Plus Sutures because the product may not match the sales unit carton and foil label.
Integra LifeSciences Corp. is recalling Tibial Total Ankle Prosthesis Trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris and Integra XT Revision ankle implants because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels incorrectly identify the metallic coating material.
Wholesome Treats, Inc. is recalling Breads from Anna Banana Bread Mix because the product contains undeclared flaxseed.
Topcon Medical Systems is recalling IMAGEnet 6 software due to a defect that may display incorrect patient identification information alongside thumbnails.
Wholesome Treats, Inc. is recalling Breads from Anna Black Bean Brownie Mix due to undeclared flaxseed.
Wholesome Treats, Inc. is recalling Breads from Anna Classic Herb Bread Mix because the product contains undeclared flaxseed.
Cays LLC is recalling 2,095 bottles of Addback Tablets because the product contains undeclared coating ingredients and lists an ingredient not in the formulation.
Philips Medical Systems is recalling 7,209 foot switches used with specific imaging systems because bent pedals may prevent live fluoroscopy images or exposures.
Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.
Integra LifeSciences is recalling Talar Dome Total Ankle Prostheses because the labels incorrectly identify the metallic coating material.
Philips is recalling 14 Brilliance 64 CT systems because a component may fail, causing ring or smudge artifacts on images.
Integra LifeSciences is recalling Salto Talaris Tibial Total Ankle Prosthesis trays because the labels list an incorrect metallic coating material symbol.