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.
The Sapphire Exchange is recalling Yum Crumbs, Strawberry Shortcake, due to undeclared Red #40. The voluntary recall covers 3,421 bottles distributed domestically.
Bovie Medical Corporation is recalling 3,862 HNM Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the barrier.
Johnson & Johnson Surgical Vision Inc is recalling 27 TECNIS Toric 1-Piece Intraocular Lenses due to the release of nonconforming products.
Bovie Medical Corporation is recalling 5,270 ConMed Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.
CooperSurgical is recalling specific lots of Milex Gellhorn Flexible pessaries because they were manufactured with incorrect stem lengths.
Dr. Reddy's Laboratories is recalling 16,449 bottles of 200 mg Progesterone Capsules because stability testing revealed out-of-specification dissolution results.
Noven Pharmaceuticals is recalling 786,900 Daytrana (methylphenidate) patches because the delivery system failed mechanical peel specifications.
Bovie Medical Corporation is recalling Velocity Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.
Barco N.V. is recalling MDNC-3421 diagnostic radiology displays because they were shipped without being DICOM-compliant. These units will not pass required acceptance tests.
G & H Wire Company is recalling orthodontic elastic bands because the patient pack text is incorrect, which could lead to misuse and temporary discomfort.
Nihon Kohden America Inc is recalling WMTS Telemetry Receivers because they may display incorrect date stamps or fail to transfer data.
Noven Pharmaceuticals is recalling 551,670 Daytrana methylphenidate patches nationwide because the delivery system failed mechanical peel specifications.
Noven Pharmaceuticals is recalling 473,280 Daytrana (methylphenidate) patches because the delivery system failed mechanical peel specifications.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the delivery system is out of specification for mechanical peel.
Boston Scientific is recalling Captivator, Captiflex, and Sensation polypectomy snares because users reported incomplete pouch seals before use.
Siemens is recalling 41 ARTIS Icono systems with software version VE20B due to misleading error messages and manual gaps that may cause procedure termination.
The General Hospital Corporation is recalling Fludeoxyglucose F 18 Injection due to a lack of assurance of sterility. The product was distributed to one direct account.
Baxter Healthcare is recalling 589,704 infusion pumps due to battery performance issues related to prolonged storage.
Dr. Reddy's Laboratories is recalling specific lots of Imatinib Mesylate 100mg tablets because they failed to meet required dissolution specifications.
Water Gardens Confections LLC is recalling 7,736 bags of Macey's Kong Popcorn found in Utah because small plastic fragments were discovered in the packaging.
Areva Pharmaceuticals is recalling 3,287 vials of Irinotecan Hydrochloride Injection due to manufacturing quality deviations identified in a Warning Letter.
Tropical Nut & Fruit Inc is recalling 7,200 units of Milk Chocolate Double Dipped Peanuts due to undeclared peanuts on the packaging.
Barron County Organics is recalling 20 Mile Coffee Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.
Barron County Organics is recalling Mint Chocolate Chip Organic Frozen Custard because ingredients were not pasteurized after blending as required by Wisconsin state regulations.
Medtronic is recalling Delta CSF flow control valves because radiopaque markings may not be clearly visible under X-ray imaging.