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.
Zimmer Inc. is correcting patient labels for 209 Metasul Durom Femoral components after complaints of reference and lot number discrepancies.
Penn State Creamery is voluntarily recalling ice cream and frozen yogurt made between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.
Penn State Creamery is voluntarily recalling ice cream and frozen yogurt produced between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects in the product.
Diagnostica Stago is recalling 237 STA Satellite Automated Multi-Parameter Analyzers because they may print incorrect INR values when using an external printer.
Penn State Creamery is voluntarily recalling Black Raspberry ice cream and frozen yogurt due to reports of small plastic foreign objects in the product.
Valeant Pharmaceuticals is recalling AcneFree Oil-Free Acne Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
Zimmer, Inc. is correcting patient labels for Dynesys L.I.S. Stabilizing Cords manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for Inverse/Reverse Screw systems manufactured before March 2010 due to discrepancies in reference and lot numbers.
Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.
Zimmer Inc. is correcting patient labels for 74 anatomical shoulder humeral inserts manufactured before March 2010 due to reported discrepancies in reference and lot numbers.
Shimadzu is recalling 288 mobile X-ray systems and related components because they may not meet federal standards for beam quality.
Penn State Creamery is voluntarily recalling ice cream and frozen yogurt made between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.
Zimmer Inc. is correcting patient labels on specific shoulder glenoid components due to discrepancies between product and patient labels regarding reference and lot numbers.
Shimadzu Medical Systems is recalling 5 mobile X-ray systems because they may not meet federal beam quality standards.
Penn State Creamery is voluntarily recalling strawberry ice cream and frozen yogurt due to reports of small plastic foreign objects in the product.
Penn State Creamery is voluntarily recalling ice cream and frozen yogurt produced between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.
Shimadzu Medical Systems is recalling 665 R-30H Diagnostic X-Ray Beam-Limiting Devices because they may not comply with 2006 product performance standards regarding beam quality.
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Ball Tapers due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for CoCr Head sterile implants manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Sirus intramedullary nails for tibia due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for 66 Anatomical Shoulder Inverse Humeral Cups due to discrepancies in reference and lot numbers.
Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because they may have bent tips. The recall affects 117,948 units distributed worldwide.
Zimmer Inc. is correcting patient labels for Dynesys Revision set screws manufactured before March 2010 due to discrepancies in reference and lot numbers.
Penn State Creamery is voluntarily recalling strawberry frozen yogurt due to reports of small plastic foreign objects in the product.