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.
Sheffield Pharmaceuticals is recalling Sheffield Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.
Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.
Exactech is recalling 235 units of InteGrip Acetabular Augments because an in-vitro biological evaluation standard was out of range.
Actavis Inc is recalling 6,540 bottles of Diclofenac Sodium and Misoprostol tablets because some tablets are broken.
Faria Limited LLC is recalling FAMILY wellness Triple Antibiotic Ointment due to elevated counts of gram-positive rods found during environmental testing.
Horiba Medical is recalling ABX PENTRA N Control units because the product was updated to include a revised Target Value assignment for Potassium.
OrthoPediatrics is recalling 12 units of 3.5mm Locking Cortical Bone Screws because the packages incorrectly contain non-locking screws.
AGFA Corp. is recalling IMPAX RIS QDOC 5.8 software because patient reports may display the wrong patient name.
Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems to meet 510(k) clearance specifications.
Highland Metals, Inc. is recalling SuperElastic NiTi archwires because some packages labeled 'Upper' contain 'Lower' archwires and vice versa.
Highland Metals, Inc. is recalling SuperElastic NiTi orthodontic archwires because some packages are mislabeled, potentially containing the wrong arch type.
Central Shared Services dba Parallon is recalling 3,764 cups of Children's Ibuprofen Oral Suspension due to discoloration and failure to meet appearance specifications.
Corepharma LLC is recalling Pyridostigmine Bromide Tablets USP 60 mg because they failed a dissolution test at the 30-month stability time point.
Forest Pharmaceuticals is recalling 3,950 packs of Namenda XR titration packs because they failed stability dissolution testing.
Nipro Diagnostics is recalling 501 units of the MooreBrand TRUEbalance Blood Glucose Monitor because they were manufactured with an incorrect factory set unit of measure.
Nipro Diagnostics is recalling 105 TRUEtrack blood glucose monitors because they were manufactured with an incorrect factory set unit of measure.
Biomerieux is recalling API Listeria kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.
Atlapac Trading Company is recalling California Girl canned Peach Halves in Juice because the cans were reported to be swollen.
Merit Medical Systems is voluntarily recalling one lot of RAD BOARD devices because missing labels may allow incorrect orientation, potentially obscuring patient anatomy during fluoroscopy.
Wockhardt USA is recalling 1,129 bottles of Pantaprazole Sodium 40 mg tablets because they failed dissolution specifications.
The Anspach Effort, Inc. is recalling 599 single-use sterile bone cutting burs because the cutters were longer than stated on the label.
Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.
Watson Laboratories is recalling 717 bottles of Hydrocodone Bitartrate and Acetaminophen tablets because the product contains broken tablets.
Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the single-use ophthalmic devices.