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 the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required dry time criteria.
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.
Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl products because environmental sampling detected Talaromyces rotundus, a fungus.
Anazao Health is recalling compounded fentanyl and morphine medications due to the detection of Talaromyces rotundus fungi in environmental samples.
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.
Anazao Health is recalling Clonidine HCL, Baclofen, and Fentanyl Citrate products due to the detection of Talaromyces rotundus fungi.
Anazao Health is recalling compounded hydromorphone, bupivacaine, baclofen, clonidine, and fentanyl 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 fails to meet the required 30-minute drying time.
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.
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 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 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 operator manual lists an incorrect minimum drying time for sterilization trays.
Anazao Health is recalling Clonidine HCL and Baclofen products because environmental sampling detected Talaromyces rotundus, a fungus.
Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.
Anazao Health is recalling hydromorphone and bupivacaine combination injections due to the presence of Talaromyces rotundus fungi detected during environmental sampling.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz sterilization tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
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.
Coast Quality Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL because environmental sampling detected Talaromyces rotundus, a fungus.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
The Binding Site Group is recalling 10 Optilite C-Reactive Protein Kits because the reagent has deteriorated. The kits were distributed in California and Georgia.
LivaNova is recalling 643 VNS Therapy Program tablets due to a software error that causes incorrect diagnostic tests on specific devices.
Leica Microsystems is recalling 558 BOND Polymer Refine Detection Kits because they were stored improperly, which may result in suboptimal staining.
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.