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.
Boehringer Ingelheim Roxane Inc. is recalling 3,553 bottles of Perindopril Erbumine Tablets, 8mg, because out-of-specification results were found for impurity B.
Perkinelmer is recalling 180 NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kits because they contain defective microplate wells.
Perkinelmer is recalling 56 kits of DBS Microplates, Truncated V-Bottomed, due to defective wells that may affect assay results.
Quanta System is recalling 22 laser surgical instruments because website promotional materials contained claims not applicable to US devices.
IDS is recalling 25-Hydroxy Vitamin D EIA kits because a quality control report contained an incorrect calibrator value.
Philips is recalling 108 CT systems because a software defect prevents users from labeling coronary arteries in rendered images.
Quanta System is recalling 12 Eterna Giovinezza laser units because its website contained promotional materials with claims not applicable to U.S. distributed devices.
James G. Cole, Inc. is recalling I-C Drops Eye Cleansing Agent because the label does not state the product is sterile, as required by FDA regulations.
Philips is recalling HeartStart HS1 defibrillators to clarify maintenance information in the Owner's Manual.
Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays due to higher imprecision and outliers on Beckman Coulter AU Systems.
Siemens Healthcare Diagnostics Inc is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.
Siemens is recalling CLINITEK Atlas Positive and Negative Control Strips because leukocyte results may become negative if the solution is held above 25°C for more than two hours.
Entegra Coach is recalling 2013 Aspire motorhomes because the certification label incorrectly identifies rear axle tire sizes, potentially leading to improper tire installation.
Advanced Sterilization Products is recalling 12,280 STERRAD NX Cassettes because it lacks adequate data to support the product's labeled shelf-life.
Siemens Healthcare Diagnostics is recalling specific lots of TSH calibrator vials because they showed under-recovery of dose values.
New B.C.N. Trading Inc. is recalling Asian Boy Tapioca Sticks because they contain undeclared sulfites. The product was distributed in six states.
Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.
Stryker is recalling specific Accolade hip stems because size 3.5 stems were mistakenly packaged as size 2.5 stems, creating a risk of product mix-up.
Philips is recalling HeartStart FRx AEDs to clarify maintenance instructions in the Owner's Manual.
Dawn Food Products is recalling Sam's Club Artisan Fresh Miniature Candy Cookies due to a labeling discrepancy involving White Chocolate Macadamia Nut Cookies.
Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.
Cooper Vision is recalling 246 units of AVAIRA Toric Contact Lenses because they exceeded the acceptance limit for silicone oil residual.
Abbott Laboratories is recalling specific lots of Synthroid (levothyroxine sodium) tablets because bottles labeled as 150 mcg actually contained 75 mcg tablets.
Beckman Coulter is recalling Access Total T4 Calibrators because specific lots do not meet their claimed 12-month expiration date.
Sanofi-Aventis is recalling the Diamigo iPhone app because it was inadvertently made available globally instead of being restricted to Brazil.