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.
Siemens is recalling the Dimension Vista Creatine Kinase MB assay because it may produce inaccurate results when used with certain drugs.
Kroger Specialty Pharmacy is recalling Altera Handset due to a lack of processing controls. The product was distributed in five states.
Bard Peripheral Vascular Inc is recalling 216 units of POWERPORT ClearVUE Slim catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Cyclophosphamide 50 mg capsules due to a lack of processing controls. The affected lots were dispensed between December 2017 and February 2018.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Kroger Specialty Pharmacy is recalling Gleevec 100 mg tablets dispensed in five states due to a lack of processing controls.
Kroger Specialty Pharmacy is recalling Sutent 37.5 mg capsules due to a lack of processing controls. The affected products were dispensed in five states between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Promacta 50 mg tablets due to a lack of processing controls. The recall affects specific lots dispensed in five states.
Kroger Specialty Pharmacy is recalling Praluent 75 mg pens due to a lack of processing controls. The affected units were dispensed in five states between December 2017 and February 2018.
Siemens is recalling Dimension Vista Thyroxine assays because sulfasalazine and sulfapyridine may cause inaccurate results.
Bard Peripheral Vascular Inc is recalling 10 units of POWERPORT ClearVUE Slim Implantable Port kits because the included Patient ID Card contains incorrect port flushing instructions.
Synthes (USA) Products LLC is recalling 196 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
Bard Peripheral Vascular Inc is recalling 2,395 units of POWERPORT ClearVUE isp catheters because the packaged Patient ID Card contains incorrect port flushing instructions.
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 Temozolomide 250 mg capsules due to a lack of processing controls. The recall affects specific lots dispensed between December 2017 and February 2018.
Kroger Specialty Pharmacy is recalling Boost VHC Oral Liquid due to a lack of processing controls. The product was distributed in five states.
Siemens Healthcare Diagnostics is recalling Dimension AST assays because they may produce inaccurate results when used with certain drugs.
Siemens Healthcare Diagnostics is recalling ADVIA Ammonia assays because sulfasalazine and sulfapyridine may cause inaccurate test results.
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions incorrectly state the biotin interference level.
Siemens Healthcare Diagnostics is recalling IMMULITE Gastrin assays because biotin interference is not listed in the instructions for use.
Bard Peripheral Vascular Inc is recalling 3,196 units of POWERPORT ClearVUE Slim catheters because the included Patient ID Card contains incorrect port flushing instructions.
Kroger Specialty Pharmacy is recalling Sodium Chloride 3% Inhalation Solution due to a lack of processing controls. The product was distributed in five states.
Kroger Specialty Pharmacy is recalling Repatha 140 mg/mL Sureclick AI 2-pk due to lack of processing controls. The recall affects units dispensed in MS, LA, AR, IL, and FL.
Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.
Integra LifeSciences Corp. is recalling Manuka Honey Wound Gel due to an incorrect part number listed in a master manufacturing record.