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 is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Eastman Footwear is recalling Coleman Runestone children's shoes because metal rivets may have sharp edges that can cause lacerations. Consumers should stop using the shoes and return them for a refund.
Siemens is recalling ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400 because specific software versions allow the systems to automatically run assay calibrations and quality control.
Ortho-Clinical Diagnostics issued an urgent product correction for the enGen Track System and enGen Select v5.0 due to an anomaly affecting the autoverification feature and custom rules.
Ecolab Inc is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Mixing Cup Arrays used on VITROS 250 and 350 systems due to an increase in software errors.
Mylan Pharmaceuticals is recalling specific lots of Levothyroxine Sodium Tablets because stability testing showed the drug was below specification.
Actavis is recalling 99 cartons of Trelstar 11.25 mg due to a labeling error where the vial was marked 3.75 mg. The product was distributed nationwide and in Puerto Rico.
Medtronic is recalling GRAFTON DBM Flex units labeled as 2.5 cm x 10 cm that actually measure 2.5 cm x 5 cm.
Stryker Howmedica Osteonics is recalling a patient-specific CMF Customized Implant Kit because an incorrect unit was delivered to a hospital in Pennsylvania.
Sysmex America is recalling 214 UF-1000i urine analyzers because a software patch error prevented proper database file purging, causing system performance issues.
Caraco Pharmaceutical Laboratories is recalling 7,005 bottles of Oxcarbazepine 300 mg tablets because some tablets are broken.
Ecolab is recalling specific lots of Microtek Medical Bur Hole Probe Covers because they did not undergo proper endotoxin testing.
Neuro Kinetics is recalling 148 Normative Data Template CDs for I-Portal devices because the data has not received FDA clearance through the 510(k) process.
RTI Surgical, Inc. is recalling 14 units of OPTEFORM Allograft Paste 5cc because they may contain a 10cc fluid dispenser with incorrect fill lines.
Ortho-Clinical Diagnostics is recalling the enGen Track System software due to an anomaly affecting the autoverification feature and custom rules.
Watson Laboratories is recalling Diclofenac Sodium and Misoprostol tablets because split tablets were found in stability samples.
Insight Instruments is recalling Cornea Coat syringes because they were marketed without an approved NDA or ANDA.
Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.
Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.
Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 25 mg tablets because they may contain impurities outside of specification limits.
Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.
Zest Anchors is voluntarily recalling specific lots of Locator Implant Attachment Systems because the product labels incorrectly state the final torque for the abutment.
Dr. Reddy's is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications and a 12-month stability interval.