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.
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
Frontier Devices 12 mm Distraction Pins in 10 single packs are recalled because the labeling includes a shelf life that has not been validated. 3,790 units are affected.
Top Secret Nutrition Extra Strength Uric Control, 30 veggie caps, lot C1238, is recalled for unapproved drug claims. The recall covers 85,950 units across the firm's affected products.
Six vials of Sandoz Cyclophosphamide Injection 500 mg/5 mL from lot 110459 are recalled nationwide after a temperature excursion during transportation.
Hi-Tech Pharmaceuticals Pine Bark, 60 tablets, lot C15Cl4, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Hi-Tech Pharmaceuticals Adderex XR, 30 tablets, lot 303120691, is recalled for unapproved drug claims and misbranding. The recall covers 85,950 units across the firm's affected products.
Frontier Devices 12 mm Distraction Pins in 10 double packs are recalled because the labeling includes a shelf life that has not been validated. 160 units are affected.
Altec is recalling certain 2022-2025 Aerial Device, Forestry Body, Service Body and Digger Derrick vehicles because the Gross Axle Weight Rating on the certification label may be incorrect.
Artis Pheno image-intensified fluoroscopic X-ray systems are recalled because of limited system movements after startup. 20 units are affected.
Sulfamethoxazole and Trimethoprim double strength tablets distributed by Cardinal Health are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.
Neuroquell and Neuroquell Plus, 0.22 fl oz, distributed by Claire Ellen Products, are recalled for cGMP violations. 72 containers sold via the internet are affected.
Iodo Blanco Iodides First Aid Antiseptic, iodine 2%, lot 230619, is recalled because of a defective container: broken or leaking bottles. 3,900 bottles distributed in Florida are affected.
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee in California.
ICEfx Cryoablation Systems are recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. 18 units are affected.
ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.
CorNeat EverPatch permanent tissue-integrating surgical matrices are the subject of a retroactive labeling correction, following complaints, to include prevention and management of wound dehiscence.
Sulfamethoxazole and Trimethoprim double strength unit dose cartons from Major Pharmaceuticals are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.
NOxBOXi Nitric Oxide Delivery Systems are recalled for replacement of the internal sample pump because of high failure rates. 1,667 units are affected.
PILLAR SA Ti sterile 37 mm intervertebral body fusion devices are recalled because the outer and inner label side flaps state an incorrect width of 33 mm. 3 units are affected.
Hershey's Ice Cream Green Mint Chip bulk 3-gallon cans, lot 25223M, are recalled after routine testing found elevated coliform counts. 81 cans are affected.
The Preventive Maintenance Kit ICEFX, batch 108159110, is recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. One unit is affected.
Organic BABY bedtime drops, a liquid dietary supplement for ages 4 months and up, are recalled in lots 25084 and 25086 because of the potential for spoilage due to yeast contamination. 85,248 bottles are affected.
Anabolic Research WINN-50, 90 capsules, lot 2307149, is recalled nationwide because degradation of an ingredient left the product subpotent for vitamin B12. 1,566 bottles are affected.
RayStation 2023B, 2024A and 2024A SP3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.