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.
AuroMedics Pharma LLC is recalling specific lots of Vancomycin Hydrochloride for Injection due to reports of discoloration after reconstitution.
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.
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 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 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 the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.
Kraft Foods Global Inc. is recalling specific boxes of Cheese Nips due to the presence of small food-grade yellow plastic pieces from a dough scraper.
Anazao Health is recalling Baclofen products after environmental sampling detected Talaromyces rotundus, a type of fungus.
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.
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 systems because the Spanish operator manual incorrectly states a 30-minute drying cycle, whereas 40 minutes are required for complete drying.
Brasseler USA is recalling 387 units of 3.5 mm twist drills that were incorrectly laser etched as 2.5 mm.
NDDd Medical Technologies is recalling 37 EasyOne Pro LAB VOS devices due to potential non-compliance with electromagnetic shielding standards.
Northern Fisheries Ltd. is voluntarily recalling specific lots of frozen tuna products due to potentially elevated histamine levels.
Northern Fisheries Ltd. is voluntarily recalling specific tuna products due to potentially elevated levels of histamine.
AuroMedics Pharma LLC is recalling Fluphenazine Decanoate Injection due to discoloration and haziness found in one vial.
Pacira Pharmaceuticals is recalling 910 vials of Exparel (Bupivacaine) because the drug was found to be sub-potent and out of specification.
NDDd Medical Technologies is recalling 37 EasyOne Pro Respiratory Analysis Systems because the CO/CO2 sensor cable harness may have insufficient electromagnetic shielding.
Miami Device Solutions is recalling 15 units of Right Proximal Humerus Plates because they may be improperly identified as left.
Medline Industries is recalling EVENCARE G3 Blood Glucose Test Strips because incomplete seals may cause the strips to expire prematurely.
Abbott is recalling Alinity ci Level Sensor Bulk Solution kits due to potential cracks caused by environmental stress, which may affect reliability.
Nextremity Solutions is recalling 49 units of Stratum Foot Plating System screws because they may contain the incorrect screw type and length.
Rocket Medical Plc is recalling 1,081 KCH Fetal Bladder Drainage Catheters due to reported kinking and off-label use for pleural drainage.