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.
Sunnyside Farms is recalling Dole Savory Spinach Dijon salad because the top label incorrectly identifies the product as Candied Walnut Salad.
Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters distributed in the US without required FDA 510(k) clearance.
The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.
Becton Dickinson is recalling 2.8 million BD Ultra-Fine Pen Needles because US cartons are missing specific compatibility information.
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.
Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.
Jubilant Cadista Pharmaceuticals is recalling 4,416 bottles of clomipramine hydrochloride capsules because they failed tablet/capsule specifications.
Fusion Health and Vitality LLC is recalling 5,000 bottles of Immune Boost because the product was marketed with drug claims without an approved NDA or ANDA.
Fresenius Kabi is recalling Doxorubicin Hydrochloride Injection vials because testing found trace amounts of octreotide.
Heritage Pharmaceuticals is recalling specific bottles of Felodipine Extended Release Tablets because routine testing found out-of-specification impurities.
Medtronic is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.
The Neil Jones Food Company is recalling Sysco Arrezzio diced tomatoes due to the presence of hard black plastic.
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.
Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill because the shaft may bind within the guide, potentially delaying surgery.
Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.
Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify the devices.
Teligent Pharma is recalling one lot of Triamcinolone Acetonide Lotion because it does not meet assay results.
Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.
FreshPoint Dallas is recalling specific lots of Roma diced tomatoes due to potential foreign material. The products were distributed in Texas and Kansas.
Milbar Laboratories is recalling Salicylic Acid Shampoo 3% due to Good Manufacturing Practice deviations. The product was distributed in the US and internationally.
Hikma Pharmaceuticals is recalling specific lots of Sodium Chloride Injection USP 0.9% 2 mL vials because they failed pH specifications.
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control and Calibrator lots due to elevated signal/cutoff values and decreased signal.
Exactech, Inc. is recalling 69 Equinoxe Cage Glenoid, Posterior Augment, Left, Medium devices because they may be mislabeled.
Coltene Whaledent is recalling 556 CEI Cutting Edge Instruments (PTC-57C) because FG 557 burs were incorrectly packaged as FG 57 burs, which may remove more material.