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.
Baxter Healthcare is recalling Spectrum IQ Infusion Systems with Dose IQ Safety Software due to a potential software error during programming.
Fresenius Kabi is recalling 4,411 trays of Sensorcaine (Bupivacaine HCl and Epinephrine) because the epinephrine component tested below specification.
GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging procedures.
Boston Scientific is recalling 772 IceRod 1.5 MRI Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.
Flowers Foods is recalling Canyon Bakehouse Gluten Mountain White Bread because some products contained higher than acceptable levels of gluten.
Biocomposites, Ltd. is recalling 54 boxes of Stimulan Kit 10cc, Model 600-010, because the product is mislabeled. The recall affects units distributed in the US, Puerto Rico, and Costa Rica.
Baxter Healthcare is recalling 140,006 SIGMA Spectrum Infusion Pumps due to a potential software error during programming.
Flowers Foods is recalling Canyon Bakehouse Gluten-Free Bagels because some products contained higher than acceptable levels of gluten.
Meijer Distribution is recalling True Goodness Organic Green Peas because the product may contain nightshade.
Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps due to a potential software error during programming.
Boston Scientific Corporation recalled 525 IceEDGE cryoablation needles due to reported gas leaks in the needle shaft, affecting nationwide distribution.
Biomet is recalling 21 units of Vanguard 360 Revision System Posterior Augments because tibial bolts were packaged instead of femoral bolts, which may delay knee arthroplasty procedures.
Dole Fresh Vegetables Inc is recalling President's Choice Coleslaw due to a deviation in the wash process. The product was in transit in Canada and destroyed.
Siemens Healthcare Diagnostics is recalling Atellica GGT Reagent because it may show repeatability imprecision outside performance data on some analyzers.
Taro Pharmaceuticals is recalling TopCare Clotrimazole Cream because an unknown degradation impurity was detected slightly above the specification limit.
Zimmer Biomet is updating instructions for Polaris and Cypher spinal screws to warn against using them with direct current stimulation due to construct failure risks.
Taro Pharmaceuticals is recalling Equate Athlete's Foot cream because an unknown impurity was detected above specification limits.
Simex Logistics SA de CV is recalling Lavar 70 Gel Hand Sanitizer because it is a subpotent drug. The product was distributed in California, Georgia, Nevada, and Texas.
Medline Industries is recalling RevMedX Trauma Dressings because of package seal integrity issues. The recall affects 15,780 units distributed in the US and several international countries.
Simex Logistics SA de CV is recalling 19,008 bottles of Health & Hand Gel Hand Sanitizer because the product is subpotent.
Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.
Simex Logistics SA de CV is recalling +Protec Hands Antibacterial Gel because it is subpotent. The product was distributed in California, Georgia, Nevada, and Texas.
Taro Pharmaceuticals is recalling HEB Clotrimazole Cream 1% because an unknown degradation impurity was detected slightly above the specification limit.
Biogen is recalling 5,307 bottles of Vumerity capsules because they failed dissolution testing. The medication may not release the drug as intended.
Boston Scientific is replacing 90 EKOS Control System 4.0 units in Latin America and the EU to prevent internal RF board failures at lower temperatures.