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.
Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.
Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.
Aesculap is recalling three ELAN 4 Fixed Duraguard Long units after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
Philips Allura Xper FD10/10 X-ray systems may lose motorized movement capability due to deterioration of internal components including the CMOS battery, hard disk drive, or power supply unit. Imaging and manual movements remain functional.
Ethicon LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot 104DBB) due to potential barb non-engagement that could affect surgical outcomes.
Biofire Defense is recalling the FilmArray NGDS Warrior Panel due to increased risk of internal control failures when testing positive blood cultures, which may delay results and require additional diagnostic evaluation.
Quick Touch Alcohol Prep Pads containing 70% isopropyl alcohol, lot 20240610, are recalled for current good manufacturing practice deviations. 500 cases are affected.
Mixed amphetamine salts extended-release capsules, 20 mg, lot GPC250179A, are recalled nationwide after failing impurities and degradation specifications. 11,909 bottles are affected.
READYPREP PVP Povidone-Iodine 10% Solution, 1 gallon bottles, lot 24EJA180, is recalled nationwide as a subpotent drug. 2,680 bottles are affected.
Kroger is recalling 1,860 bottles of its 70% Isopropyl Alcohol, 5.5 oz, from a single lot because of cross contamination with other products.
Mixed amphetamine salts extended-release capsules, 15 mg, lot GPC250178A, are recalled nationwide after failing impurities and degradation specifications. 9,917 bottles are affected.
Mixed amphetamine salts extended-release capsules, 10 mg, lot GPC250159A, are recalled nationwide after failing impurities and degradation specifications. 11,895 bottles are affected.
Zimmer Biomet is recalling JuggerKnot Mini Soft Anchors after outer cartons labeled for the 1.0mm Mini product were found to contain 1.4mm Short devices instead.
TopCare Health 70% Isopropyl Alcohol, 5.5 oz cans, lot 0662036, distributed by Kroger, is recalled for cross contamination with other products. 60 units are affected.
Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and imaging functionality remain available.
Mixed amphetamine salts extended-release capsules, 30 mg, lot GPC250181A, are recalled nationwide after failing impurities and degradation specifications. 11,928 bottles are affected.
Glenmark Azelaic Acid Gel, 15%, 50 gram tubes from batch 19252524, is recalled nationwide after market complaints of a gritty or grainy texture. 13,824 tubes are affected.
Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.
Boston Scientific Corporation is recalling Extractor Pro RX Retrieval Balloon Catheters because the label incorrectly indicates the position of the skive hole relative to the balloon.
UDK Half Plum, 170 g containers, is recalled because of cyclamate adulteration. 29 cases distributed in four states are affected.
MMBAL pasteurized donor human milk, 100 mL bottles from batch 001868-3, is recalled because of a potential physical contaminant. 25 bottles distributed in Alabama are affected.
Goldband Snapper skin-on frozen fillets, 8-10 oz, are recalled because testing confirmed the fish is Sharptooth Snapper. 925 cases are affected.
PrimeNutrition Phytoform Fruits & Greens Formula in watermelon, 13.75 oz, lot 174271126, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
PrimeNutrition Phytoform Fruits & Greens Formula in peach mango, 13.75 oz, lot 202140114, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.