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 30 units of Convenience Kits containing Medline catheters because samples failed performance specifications.
Hikma Pharmaceuticals is recalling specific lots of Ramipril 10 mg capsules because they failed impurity specifications for dicyclohexylurea.
Fujifilm is recalling Synapse PACS software v7.4.310 because a software issue may cause ruler measurements to be inaccurate.
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.
Olympus is recalling 335 PowerSeal 5 mm Sealer & Divider devices because the outer shelf box is incorrectly labeled as a 37-cm device.
AVID Medical is recalling 78 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
AVID Medical is recalling 120 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
ConMed is recalling specific suture anchors because they may contain incorrect patient implant cards, which could lead to incorrect device identification and traceability.
Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.
AVID Medical is recalling 78 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.
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 is recalling 63 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.
AVID Medical, Inc. is recalling 130 Halyard Total Joint kits because the labeling fails to identify that the statlock component contains natural rubber latex.
AVID Medical, Inc. is recalling 78 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 Medline catheters failed performance specifications.
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% because it failed content uniformity specifications. The recall covers 5,082 tubes distributed nationwide.
Medline is recalling 45 Trach Tube Kits (SKU DYKM2330) due to a component labeling discrepancy. The recall covers units distributed in California.
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.
FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.
Foundation Medicine is recalling 32 Hamilton Microlab STAR Liquid Handler units due to a software issue causing spontaneous closures.
Prospector Popcorn is recalling Chocolate Mocha Gourmet Popcorn because the label understated carbohydrate and cholesterol levels.
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.