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.
Arrow International Inc. is recalling Arrow Maximal Barrier Drapes because the product lidstock contains the incorrect expiration date.
CSM Bakery Products is recalling frozen chocolate chip cookie dough because pieces of plastic polymer were introduced into the sugar system.
Nobel Biocare is recalling 59 dental drills because a packaging defect may compromise sterility. The devices are distributed worldwide.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Enzymatic Creatinine reagent because phenindione therapy can cause falsely depressed results.
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Ethicon, Inc. is recalling three units of Stratafix Spiral PDS Plus Violet sutures because they do not meet internal testing specifications.
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Nobel Biocare is recalling 526 Implant Retrieval Instruments because a packaging sealing issue may compromise sterility during shelf life.
Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal testing specifications.
Arrow International Inc. is recalling 205 units of the FlexTip Plus Epidural Catheterization Kit because the product lidstock contains the incorrect expiration date.
Prollenium Medical Technologies is recalling 48,457 kits of Revanesse Versa because the product is labeled with an 18-month expiration date, but it is only approved for 12 months.
Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.
CooperVision is recalling specific lots of Vertex Toric contact lenses because they were manufactured with an incorrect power.
CooperVision is recalling 216 units of Vertex Toric contact lenses because they have an incorrect power than expected.
Lupin Pharmaceuticals is recalling 6,294 bottles of Memantine Hydrochloride Extended Release Capsules because they failed to meet dissolution specifications during stability testing.
Sugar Foods Corporation is recalling specific lots of granulated pure cane sugar sold under Ahold, N'Joy, and Speedway brands because the product may be contaminated with foreign material.
Nextremity Solutions is recalling 40 Stratum Lapidus Plate units because the package labeling indicates a right plate, but the product contains a left plate.
C.R. Bard Inc. is recalling 1,300 units of the Bard Intra-abdominal Pressure Monitoring Device due to leaks or disconnects that may cause inaccurate readings.
GSK is recalling Theraflu Cough Relief packets because the label lacks a warning for people on sodium-restricted diets.
Morton Salt Inc. is recalling 26 oz canisters of iodized salt that were incorrectly labeled as plain salt, resulting in undeclared dextrose and potassium iodide.
DePuy Orthopaedics is recalling 140 Specialist 2 Distal Femoral Cutting Blocks because they will not connect to the required outrigger, rendering them unusable in surgery.
Teva Pharmaceuticals USA is recalling 17,436 bottles of Methylphenidate Hydrochloride Extended-Release tablets because the product bottles may be missing desiccant.
LivaNova USA Inc is recalling six VNS Therapy SENTIVA Generator Model 1000 units because they were sterilized one additional cycle, failing to meet quality specifications.
Pfizer is recalling 141 bottles of Caduet tablets because defective bottle rims may have allowed moisture to enter, potentially compromising the medication.