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.
Grato Holdings is recalling Peaceful Mountain Nasal Rescue dietary supplements because they are unapproved new drugs based on disease claims.
Kroger Specialty Pharmacy is recalling Taltz 80 mg/mL pens distributed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Altera Handset due to a lack of processing controls. The product was distributed in five states.
Hyphen BioMed is recalling ZYMUTEST HIA MonoStria kits because the package insert incorrectly lists serum and other fluids as valid sample types.
Siemens Healthcare Diagnostics is recalling IMMULITE Vitamin B12 assays because biotin interference is not listed in the instructions for use.
Siemens Healthcare Diagnostics is recalling Dimension Ammonia assays because they may produce inaccurate results when used with certain drugs.
Siemens Medical Solutions is recalling Syngo.Via VB20A software because corrected report values are not saved or transmitted, causing the system to use original values.
Kroger Specialty Pharmacy is recalling Stelara 90 mg/MI PFS due to lack of processing controls. The recall affects units dispensed in five states between December 2017 and February 2018.
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.
Kroger Specialty Pharmacy is recalling Otezla 30 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling the Dimension Creatine Kinase MB (MBI) assay because it may produce inaccurate results when used with certain drugs.
Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.
Kroger Specialty Pharmacy is recalling Boost VHC Oral Liquid due to a lack of processing controls. The product was distributed in five states.
Grato Holdings, Inc. is recalling Energique Enervimin CNCR Focus dietary supplements because they are unapproved new drugs based on disease claims.
Bard Peripheral Vascular Inc is recalling 15 units of POWERPORT ClearVUE isp Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.
MHC Medical Products LLC is recalling EasyTouch Insulin Syringes because retail cartons may display incorrect lot numbers.
Diagnostic Hybrids, Inc. is recalling 1004 units of the MicroVue BAP EIA Model 8012 because standard bottles may have low volume or leak.
Siemens is recalling Dimension Vista ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Kroger Specialty Pharmacy is recalling Revlimid 5 mg oral capsules due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Hyphen BioMed is recalling 12 ZYMUTEST HIA MonoStrip IgG kits because the package insert incorrectly lists serum and other fluids as valid sample types.
Bard Peripheral Vascular Inc is recalling 835 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.
Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc IgM tests because the instructions do not list the biotin concentration limit, making the assay susceptible to interference.