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.
One True Metrix Air blood glucose meter is being recalled because it displays results in mmol/L instead of mg/dL.
Beckman Coulter is recalling Access Free T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.
Osteomed, LLC is recalling 70 units of Osteovationex 2cc Inject Formula because the product may not maintain its setting characteristics for the labeled shelf-life duration.
Osteomed, LLC is recalling Osteovationex 3cc Inject Formula bone void fillers because the product may not maintain its setting characteristics for the labeled shelf-life duration.
American Contract Systems is recalling 2,868 sterile surgical kits because they were manufactured in a facility not registered with the FDA.
Teva Pharmaceuticals USA is recalling specific bottles of mixed amphetamine salts tablets because some may contain mixed strengths.
Triova Pharmaceuticals is recalling Estriol USP Micronized 5 G because the product failed specifications for organic impurities.
Olympus is recalling 18 ShockPulse-SE Lithotripsy System transducers because a component was made with non-conforming material that could allow water ingress during sterilization.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Osteomed, LLC is recalling Osteovation 10 CC Impact Formula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers because they may have insufficient aspiration capabilities, potentially resulting in lost samples.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.
Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers because they may have insufficient aspiration capabilities, resulting in lost samples.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers because they may have insufficient aspiration capabilities, resulting in lost samples.
American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Beckman Coulter is recalling Access Total T3 Triiodothyronine assays because high levels of biotin can cause significant result bias.
Beckman Coulter is recalling Access GI Monitor Cancer Antigen 19-9 assays because biotin can cause significant result bias.
Inpeco is recalling 97 Accelerator a3600 Automation Systems because a firmware error may dilute primary samples with distilled water during clot detection.
Nobel Biocare is recalling specific dental implant healing abutments because they were packaged with the wrong size device.
Abbott is recalling Afinion 2 and Alere Afinion AS100 power supplies due to a risk of electrostatic discharge and sparking that can render the unit non-functional.
Osteomed is recalling 300 units of Osteovationex 5cc ImpactFormula bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
Osteomed, LLC is recalling 651 units of Osteovation RMX 10 CC Injectable bone void filler kits because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
Osteomed, LLC is recalling 153 units of Osteovationex 3cc ImpactFormula bone void filler because the labeled shelf-life may be incorrect, potentially affecting the product's setting characteristics.
Osteomed is recalling 278 units of Osteovation RMX Injectable Bone Void Filler kits due to incorrect shelf-life labeling that may affect product setting characteristics.