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.
Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.
Frobright Salsary, LLC is recalling San Juan Salsa Mild Salsa due to potential contamination with wood particles. The 14 oz refrigerated product was distributed in Alaska, Idaho, Oregon, and Washington.
Kenil Healthcare is recalling 10,000 tubes of Rapidol Maximum Strength Hydrocortisone 1% Anti-Itch Cream (2 oz, Lot SP26A, Expiration 09/30/2026) distributed in Delaware and North Carolina due to manufacturing quality issues.
Maximum Security Anticavity Gel Toothpaste is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 391,680 tubes distributed in Delaware and North Carolina.
KOFAL Athletes Penetrating Pain Relief external analgesic ointment (methyl salicylate 10.5%) is being recalled due to CGMP deviations in manufacturing. The voluntary recall affects 11,808 jars distributed in Delaware and North Carolina.
KENIL HEALTHCARE PRIVATE LIMITED is recalling Nature Mint Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 19,500 tubes distributed in Delaware and North Carolina.
Philips is recalling MR 5300 medical devices (Model Numbers 782110 and 782152) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Augmedics Ltd. is recalling the Perc Pin Adaptor, a component of the xvision Spine surgical navigation system, because the tightening knob is inconvenient to use and the tightening markings are improperly placed.
Wells Enterprises is recalling Johnny Rockets Vanilla Flavored Ice Cream (3-gallon tubs) because plastic material may be present in the product.
Wells Enterprises is recalling Mocha Almond Fudge Ice Cream (3-gallon tubs) because plastic fragments may be present in the product. Consumers should not consume the affected product.
Wells Enterprises is recalling Cotton Candy Flavored Ice Cream 3-gallon tubs because foreign plastic material may be present in the product.
Richard Wolf GmbH is recalling 31 PiezoWave 2 Control Units (Product Number 100506US) due to a high voltage capacitor that may fail early in the device's life cycle, potentially producing smoke, burning smell, spark, or excessive heat.
Foundation Medicine is recalling four FoundationOne Companion Diagnostic (F1CDx) test reports sent to customers that contained clinically relevant variants requiring amendment, including one with an incorrect negative companion diagnostic claim.
Wells Enterprises is recalling GFGB Vanilla Bean Flavored Ice Cream in 3-gallon tubs because plastic material may be present in the product.
Glenview Farms Artificially Flavored French Vanilla Ice Cream in 3-gallon tubs is being recalled because plastic material may be present in the product. Consumers should not consume the product.
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3012) due to mislabeling. Thirty-four weights distributed nationwide are affected.
Medline Industries is recalling Centurion Sterile Weitlaner Retractors (2,100 units) due to potential puncture damage to sterile packaging. The defect could compromise the sterility of the surgical instrument.
AVID Medical is recalling Halyard CHRIST SUTURE KIT units due to a raw material issue in the needle coating that may cause silicone to be removed during use, potentially affecting surgical performance.
Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer due to a software error that prevents the analyzer from completing calibration orders under certain conditions, which can delay test result reporting.
Meddev Corp is recalling Contour Gold Eyelid Weight implants (Model LL3010, 1.0 gm) due to mislabeling. The recall affects 34 units distributed nationwide across 17 states.
Wells Enterprises is recalling Vanilla Bean Ice Cream (3-gallon tubs) distributed by US Foods because plastic material may be present in the product.
Wells Enterprises is recalling 3-gallon tubs of vanilla flavored ice cream due to the possible presence of plastic foreign material in the product.
Wells Enterprises is recalling Country Rich Vanilla Ice Cream 3-gallon tubs because plastic foreign material may be present in the product.
Wells Enterprises is recalling BIPC Flavored Ice Cream 3-gallon tubs because plastic foreign material may be present in the product.
Wells Enterprises is recalling Glenview Farms Vanilla Flavored Ice Cream 3-gallon tubs because plastic foreign material may be present in the product.