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 Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
JBS USA is recalling approximately 35,464 pounds of raw ground beef products that may contain hard plastic pieces. The products were distributed to retail locations in Virginia and Indiana.
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to potential sterile packaging seal failures.
Keystone Dental Inc is recalling 19 Genesis Surgical Cassettes because extra-large grommets cause dental burrs to wobble.
Time-Cap Laboratories is recalling various strengths of ibuprofen tablets due to odor complaints related to CGMP deficiencies.
Zimmer Biomet is recalling Smooth Guide Wire Bullet Tip products because the sterile packaging seal may fail, potentially compromising sterility.
Accelerate Diagnostics is recalling 95 PhenoTest BC kits because they may produce false positive results for Staphylococcus aureus.
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.
Howmedica Osteonics Corp. is recalling 77 Triathlon Revision Knee implants because customers may receive the incorrect size from what is labeled on the box.
Crimson Trace is recalling 184,390 laser sights for firearms because some units exceeded the 5 mW power output limit.
Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because of a potential failure of the sterile packaging seal.
Lyne Laboratories is recalling 12,572 units of Fluocinolone Acetonide Topical Oil because the product is subpotent. The recall is voluntary and was initiated by the firm.
McKesson Packaging Services is recalling Diltiazem CD 180 mg capsules because stability testing showed high dissolution results.
Stryker GmbH is recalling 18 Hinge Coupling Hoffmann LRF units because connecting nuts were incorrectly packed in hinge coupling packaging.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific bottles of Ibuprofen 200 mg caplets due to odor complaints linked to CGMP deficiencies.
Diagnostic Hybrids, Inc. is recalling 72 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.
Time-Cap Laboratories is recalling specific lots of Ibuprofen 800 mg tablets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen 600 mg tablets due to odor complaints linked to CGMP deficiencies.
Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.
Zimmer GmbH is recalling specific Avenir Muller Stem implants because a potential commingle may cause the product in the package to not match the outer label.
McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, 240 mg, because stability testing showed high dissolution results.
Diagnostic Hybrids, Inc. is recalling 101 MicroVue CIC-C1q EIA kits because the standard curve slope may fail validation requirements.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Caplets 200 mg due to odor complaints and CGMP deficiencies. The recall covers nationwide distribution.