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.
The Gatorade Puerto Rico Co is recalling Gatorade Melon beverages due to mold contamination. Consumers should stop using the product.
Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.
Zimmer Biomet is recalling specific lots of orthopedic stems because they may be mislabeled, potentially extending surgery time by up to 30 minutes.
CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.
CAO Group, Inc. is recalling FastStat Topical Hemostat Introductory Kits because cGMP violations were noted during the firm's most recent inspection.
The Binding Site Group is recalling 60 units of Human IgM Kits due to challenges in validating the calibration curve, indicated by control values outside specified ranges.
COVIDIEN LLC is voluntarily recalling 1,522 Salem Sump Dual Lumen Stomach Tubes because one lot of 10 Fr tubes was incorrectly packaged in 16 Fr pouches.
The Gatorade Puerto Rico Co is recalling 200 cases of Gatorade Cool Blue due to mold contamination. Consumers should discard the product.
CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.
Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with expiration dates that extend shelf life beyond validated testing.
Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
The Gatorade Puerto Rico Co is recalling Gatorade Frost Glacier Freeze 600 mL bottles due to mold contamination. The recall covers 684 cases distributed to domestic consignees.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Lemon Lime due to mold contamination. Consumers should check lot numbers and expiration dates.
The Gatorade Puerto Rico Co is recalling specific lots of Gatorade Grape due to mold contamination. Consumers should discard the affected product.
Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.
CAO Group, Inc. is recalling SHEER DesenZ Desensitizing Treatment because cGMP violations were noted during the firm's most recent inspection.
Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate 300 mg tablets because they failed dissolution specifications during stability testing.
CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.
CIVCO Medical Instruments is recalling 613 boxes of Needle Guide Starter Kits due to missing product labeling on reusable brackets.
CIVCO Medical Instruments is recalling 468 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Tosoh Bioscience is recalling AIA-900 and AIA-2000 analyzers due to a potential incubator slippage issue that may cause system errors and delays in patient test results.
The Gatorade Puerto Rico Co is recalling Gatorade Combo multipacks due to mold contamination. Consumers should stop using the affected products.
CAO Group, Inc. is recalling BeeGentle Honey Flavored Topical Anesthetic because of current Good Manufacturing Practice (cGMP) violations found during a recent FDA inspection.
CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.