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.
American Contract Systems Inc is recalling 12 Convenience Kits containing Medline catheters because samples failed performance specifications.
Henry Schein Inc. is recalling specific lots of Structur 2 SC Temporary Resin Cartridge Refills because they were distributed with incorrect packaging and Instructions for Use.
Henry Schein Inc. is recalling specific lots of Grandio Universal Nano-Hybrid Restorative Material capsules because they were distributed with incorrect packaging and Instructions for Use.
AVID Medical, Inc. is recalling 78 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
Horizon Organic Dairy is recalling shelf-stable chocolate milk due to potential spoilage. The product was distributed throughout the United States.
American Contract Systems Inc is recalling 30 units of Convenience Kits containing Medline catheters because samples failed performance specifications.
Medline is recalling 45 Trach Tube Kits (SKU DYKM2330) due to a component labeling discrepancy. The recall covers units distributed in California.
AVID Medical is recalling 63 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
American Contract Systems Inc is recalling 30 units of Convenience Kits because the included Medline catheters did not meet performance specifications.
Africando Foods LLC is recalling 720 jars of Alfredo Hot Sauce because wheat and soybean oil are missing from the ingredient list.
AVID Medical, Inc. is recalling 130 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 150 mcg tablets because they may contain less active ingredient than labeled.
Jayco is recalling 2027 Heartland Bighorn recreational trailers because the Gross Axle Weight Rating on the certification label may be incorrect, potentially leading to overloading.
Prospector Popcorn is recalling Chocolate Mocha Gourmet Popcorn because the label understated carbohydrate and cholesterol levels.
Shilpa Medicare is recalling 9,489 vials of PEMRYDI RTU (pemetrexed disodium) due to reports of green to dark green discoloration in the solution.
Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.
Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.
Gentherm Medical is recalling 182 Blanketrol II Model 222S thermal regulating systems because overheating of the 115V CPU board may cause the device to shut down.
Prospector Popcorn is recalling Fudge Brownie Gourmet Popcorn because the packaging incorrectly lists higher amounts of potassium and calcium than the product actually contains.
Spectral Instruments Inc is recalling 35 Ami HTX units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
Kico Knee Innovation is recalling 78 ARVIS Surgical Navigation System Gen 2 units because an internal sensor issue may cause the eyepiece image to appear tilted.
Golden State Medical Supply is recalling 1,200 bottles of Carbamazepine 200mg tablets due to tablets containing black specks.
Spectral Instruments Inc is recalling 40 Lago X units because the 'X-Ray On' banner may briefly disappear during the run readiness check.
FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.
Mylan Pharmaceuticals is recalling Acamprosate Calcium tablets that failed to meet dissolution specifications.