Severity 1 of 5
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.
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 Anatomical Shoulder Humeral stems due to discrepancies in reference and lot numbers.
Valeant Pharmaceuticals is recalling AcneFree 3-in-1 Acne Night Repair Foam because the salicylic acid ingredient is subpotent and the label is inaccurate.
Zimmer, Inc. is correcting patient labels for Metasul LDH Head Rx Sterile products manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer, Inc. is correcting patient labels for 139 Anatomical Shoulder Fracture Humeral stems due to discrepancies between product and patient labels regarding reference and lot numbers.
Zimmer Inc. is correcting patient labels for Dynesys Top-Loading System Cannulated Pedicle + Set Screws manufactured before March 2010 due to discrepancies between product and patient labels.
Siemens Healthcare Diagnostics is recalling 583 cartons of Dimension Vista Homocysteine Reagent Cartridges because they are leaking from their wrappers.
Clinical Diagnostic Solutions is recalling specific lots of Boule Con-Diff Hematology Control vials due to a received complaint.
Valeant Pharmaceuticals is recalling AcneFree Severe Maximum Strength Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors.
Zimmer, Inc. is correcting patient labels for NCB-PH Plates manufactured before March 2010 due to discrepancies in reference and lot numbers.
Zimmer Inc. is correcting patient labels for Fitmore Hip Stems manufactured before March 2010 due to discrepancies between product and patient labels regarding reference and lot numbers.
Clinical Diagnostic Solutions is recalling Boule Con-Diff hematology control vials due to a received complaint. The product is used to monitor multi-parameter hematology instruments.
Roche Molecular Systems is recalling 44 kits of the cobas 4800 BRAF V600 Mutation Test because internal-use controls were incorrectly packaged into the product.
Beckman Coulter is recalling Synchron Multi Calibrator Diskettes because some units may be mislabeled as Thyroxine (T4) Reagent Calibrator Diskettes.
Ormco/Sybronendo is recalling 148 Damon 3MX Bicuspid Brackets because they were produced with incorrect dark blue ID dots instead of purple, leading to misidentification as maxillary central incisor brackets.
ABC Compounding Company Inc. is recalling 66 rolls of QS Plus Hand Sanitizing Wipes found to be contaminated with graffiti remover.
Baxa Corporation is recalling Repeater Pump models 095, 099, and 099R because the included Technical Manual contradicts the Operator Manual regarding multiple source container use.
Boston Scientific is recalling LeVeen Standard Needle Electrode Systems because the Portuguese instructions for use are incorrect. The recall affects units distributed in Brazil, Portugal, and Hong Kong.
Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4.0 and later due to potential calculation errors in the Online Entry application.
Sandoz Incorporated is recalling specific lots of Children's Cetirizine Hydrochloride Chewable Tablets because they exceeded impurity specifications.
Actavis Mid Atlantic LLC is recalling Prometh VC Plain bottles because they do not meet stability specifications for an unknown degradant.
Mothers' Milk Bank at Austin is recalling 54 bottles of pasteurized human milk due to the potential presence of foreign materials.
Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.
McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets because they failed USP dissolution test requirements.
Mylan Pharmaceuticals is recalling 31,867 bottles of Famotidine Tablets USP, 20 mg, due to out-of-specification results for related compounds found during routine stability testing.
Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.