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.
Beckman Coulter is recalling Access CEA Assay reagent packs because they were filled incorrectly. The recall covers 11,406 units distributed worldwide.
Tyson Foods is recalling approximately 52,486 pounds of fully cooked hot wings due to possible adulteration from an off odor.
Graco is recalling specific Milestone child seats because they lack a required label phrase regarding LATCH system usage. Owners will receive free replacement labels.
Valeant Pharmaceuticals is recalling specific bottles of Fenoglide (fenofibrate) 120 mg tablets because they failed 24-month dissolution testing.
Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.
Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.
Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.
ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.
Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.
ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.
Barco Inc. is recalling specific surgical display models because user settings are lost when the systems are powered off and back on.
Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.
Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.
ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.
ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.
Philips is recalling 264 GEMINI PET/CT systems because the CT subsystem's Spindle Block Servo Controllers may fail prematurely.
Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.
My Dad's Favorite Cookies is recalling assorted cupcakes and bundt cakes in Arizona due to undeclared artificial food dyes.
Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.
My Dad's Favorite Cookies is recalling red velvet bundt cakes and cupcakes in Arizona due to undeclared food dyes.
Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.
Sobisk Foods LLC is recalling Strawberry Cream Cookies from India because they contain undeclared food dyes, including FD & C Red #3 and Yellow #6.
Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.