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.
Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
American Medical Systems is recalling 16,710 Sureflex 365 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Wockhardt USA is recalling 848 pouches of 15 mg Lansoprazole Delayed-Release Capsules because the firm did not adequately investigate customer complaints.
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
Wockhardt USA is recalling 68,969 bottles of Captopril 100 mg tablets because the firm did not adequately investigate customer complaints.
Perkinelmer is recalling 53 WIZARD2 gamma counters because a barcode label error may produce erroneous results.
American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new FDA guidance for reusable products.
Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.
Biomet is recalling 18 Oxford Femoral Drill Guide Lateral IM Adapters because an undersized diameter may interfere with a specific IM Link component.
Eizo is recalling RadiForce RX650 LCD monitors that may display abnormally when connected to specific graphics boards using DisplayPort.
Kremers Urban Pharmaceuticals is recalling 16,504 boxes of Nitroglycerin Transdermal Systems because two lots failed impurity specifications during stability testing.
Tortilleria Provincia is recalling Yellow Corn Tortillas because the packaging labels were incorrectly used for Blue corn tortillas, creating a labeling discrepancy.
Agfa Healthcare is recalling two IMPAX Agility PACS units in Missouri due to a software error that displayed incorrect patient names.
Exactech, Inc. is recalling four Ambassador Cervical Plate Systems that were shipped to a single consignee in Florida before final inspection was completed.
Dr. Pepper Snapple Group is recalling Diet Bubba Cola because the label fails to declare specific ingredients and displays the wrong product type.
Megabusiness LLC is recalling Del Campo Alino Casero Seasoning Paste because it contains undeclared preservatives, Benzoic Acid and Sorbic Acid.
Tortilleria Provincia is recalling White Corn Tortillas because the packaging labels were incorrectly shared with other tortilla varieties, resulting in inaccurate ingredient and color listings.
Tortilleria Provincia is recalling Blue Corn Tortillas because the packaging incorrectly lists ingredients and color additives intended for other tortilla varieties.
Nidek Inc is recalling 22 units of GYC-1000 laser accessories because they are missing required Laser Aperture labels.
Hospira Inc. is recalling specific lots of Ketorolac Tromethamine Injection due to the presence of crystals identified as the calcium salt of Ketorolac.
Nidek Inc is recalling GYC-1000 laser accessories because they are missing Laser Aperture labels. The affected units were distributed to 13 US states.
Synthes (USA) Products LLC is recalling 100 units of 16mm Chisel Blades that were incorrectly etched as 16mm when they are actually 10mm.
Exactech, Inc. is recalling two Single Barrel Drill Guides shipped to a single consignee in Florida before final inspection was completed.
Musculoskeletal Transplant Foundation is recalling 117 Allofix Insertion Kits because they are labeled as 2.0mm but may contain 2.4mm drills.
Hospira Inc. is recalling Ketorolac Tromethamine Injections because crystallization was identified as the calcium salt of Ketorolac.