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 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Anazao Health is recalling Morphine Sulfate products because environmental sampling detected Talaromyces rotundus, a type of fungus.
Volcano Corporation is recalling FFR software due to interoperability issues when connected to specific Hemodynamic Systems.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual lists an incorrect minimum drying time for sterilization trays.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl products because environmental sampling detected Talaromyces rotundus, a fungus.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Morphine Sulfate, Fentanyl Citrate, and Baclofen products due to the detection of Talaromyces rotundus fungi.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the Spanish operator manual incorrectly states a 30-minute drying cycle, whereas 40 minutes are required for complete drying.
Young Dental Manufacturing Co, LLC is recalling Oral-B 5% Sodium Fluoride Varnish because the product shelf life may be shorter than indicated on the label.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling compounded hydromorphone, bupivacaine, baclofen, clonidine, and fentanyl products due to the detection of Talaromyces rotundus fungi.
Anazao Health is recalling Clonidine HCL, Baclofen, and Fentanyl Citrate products due to the detection of Talaromyces rotundus fungi.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Pfizer is recalling 77,100 syringes of 25% Dextrose Injection because the expiration date printed on the syringes is incorrect.
Anazao Health is recalling Baclofen products after environmental sampling detected Talaromyces rotundus, a type of fungus.
Integra LifeSciences is recalling C7000 CUSA Clarity systems because the operator manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time criteria.