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 Allura Xper FD10C interventional X-ray systems because the BIOS battery may deplete faster than designed, halting system start-up with no prior warning.
Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.
Aesculap is recalling one ELAN 4 Fixed Duraguard unit after the Standard version was labeled as "Long" and the Long version was labeled as "Standard".
Philips is recalling four Allura Xper FD20 Biplane OR Table systems because the BIOS battery may deplete faster than designed, stopping the system starting.
Beckman Coulter is recalling 116 DxC 500 AU modules because a clinical chemistry sample can remain In Progress with no error when an immunoassay test is processed between chemistry tests.
Toasted Almond & Cherry Biscotti is being recalled because the colour additive Red 40 is not declared on the label. The recall covers 172 cases.
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.
Quick Touch Alcohol Prep Pads containing 70% isopropyl alcohol, lot 20240610, are recalled for current good manufacturing practice deviations. 500 cases 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.
READYPREP PVP Povidone-Iodine 10% Solution, 1 gallon bottles, lot 24EJA180, is recalled nationwide as a subpotent drug. 2,680 bottles are affected.
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.
Mixed amphetamine salts extended-release capsules, 20 mg, lot GPC250179A, are recalled nationwide after failing impurities and degradation specifications. 11,909 bottles 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.
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.
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.
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.
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.
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.
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.
Mixed amphetamine salts extended-release capsules, 15 mg, lot GPC250178A, are recalled nationwide after failing impurities and degradation specifications. 9,917 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.
UDK Half Plum, 170 g containers, is recalled because of cyclamate adulteration. 29 cases distributed in four states 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.
Mixed amphetamine salts extended-release capsules, 30 mg, lot GPC250181A, are recalled nationwide after failing impurities and degradation specifications. 11,928 bottles are affected.
iForce Nutrition Joint Help dietary supplement, 120 capsules, lot 101330812, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.