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.
Penn State Creamery is voluntarily recalling vanilla frozen yogurt due to reports of small plastic foreign objects in the product.
Penn State Creamery is voluntarily recalling German Chocolate Cake ice cream due to reports of small plastic foreign objects in the product.
Zimmer Inc. is correcting patient labels for Biolox delta Ceramic Femoral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.
Ormco/Sybronendo is recalling Vector TAS Modular Drivers because foreign language instructions list the wrong sterilization temperature.
Zimmer Inc. is correcting patient labels for MS-30 Stems manufactured before March 2010 due to discrepancies in reference and lot numbers.
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 for 228 anatomical shoulder implants manufactured before March 2010 due to reported discrepancies between product and patient labels.
OrthoPediatrics Corp is recalling 78 trochar scalpel instruments that were not manufactured to design specifications and will not function as intended.
Zimmer, Inc. is correcting patient labels for 26 Anatomical Shoulder Fracture Humeral Head units due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for MS-30 Proximal Positioners manufactured before March 2010 due to discrepancies in reference and lot numbers.
Clinical Diagnostic Solutions is recalling Boule Con Diff US Tri Pack hematology controls due to customer reports of inaccurate MCV and RDW% values.
Valeant Pharmaceuticals is recalling AcneFree Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.
Zimmer Inc. is correcting patient labels for Mueller Low Profile Cups manufactured before March 2010 due to reference and lot number discrepancies.
Sunquest Information Systems is recalling Sunquest Laboratory version 7.0 because a software defect can cause user-defined data to be incorrectly replaced.
Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.
Penn State Creamery is voluntarily recalling Cookies-N-Cream ice cream due to reports of small plastic foreign objects in the product.
Zimmer Inc. is correcting patient labels for Wagner SL Revision Stems due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for MS-30 Distal Centralizers manufactured before March 2010 after receiving four complaints regarding reference and lot number discrepancies.
Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance standards for beam quality.
Zimmer, Inc. is correcting patient labels for DTO Implants manufactured before March 2010 due to discrepancies in reference and lot numbers.
Philips Medical Systems is recalling 11 units of Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and distribution.
Sechrist Industries is recalling 65 monoplace hyperbaric chambers to fix a software bug that could affect performance.
Penn State Creamery is voluntarily recalling specific ice cream and frozen yogurt products due to reports of small plastic foreign objects.
Zimmer, Inc. is correcting patient labels for Alloclassic SL Shafts manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for BioloX Option Ceramic Femoral Head Systems manufactured before March 2010 due to discrepancies in reference and lot numbers.