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.
Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.
Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Kits due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.
Smith & Nephew is recalling 18 units of Genesis II knee bushings because the left and right sides were incorrectly laser marked.
Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.
Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.
Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.
LivaNova USA is recalling 70 units of Inspire 8 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.
Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
ConvaTec is recalling 200 boxes of Esteem Synergy Stomahesive skin barriers because the stoma hole is larger than the 22mm size specified on the label.
CooperSurgical is recalling 500 units of the Fischer Cone Biopsy Excisor, Medium, because the products were packaged with an incorrect product size.
Ethicon Endo-Surgery is recalling 1,500 units of 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.
Beckman Coulter is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and associated broth due to quality control testing failures.
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.
Sun Pharmaceutical Industries is recalling one lot of Sulfamethoxazole and Trimethoprim tablets because polyethylene was detected in two tablets.
Mylan Pharmaceuticals is recalling specific lots of Amlodipine and Benazapril HCL Capsules because the cleaning process for manufacturing equipment was not followed according to procedure.
Milbar Laboratories is recalling 4,815 tubes of Naturmetic SPF 50 Sunscreen due to Good Manufacturing Practice (GMP) deviations.
Prescript Pharmaceuticals is recalling Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets due to a storage temperature labeling discrepancy.
Prescript Pharmaceuticals is recalling 50 containers of Clindamycin 150 mg capsules in California due to a storage temperature labeling discrepancy.
Volcano Corporation is recalling eight Philips Volcano CORE M2 Vascular Systems because an incorrect resistor causes noise and overly bright images.
Pharmalucence, Inc. is recalling Technetium TC 99M Mebrofenin kits nationwide because they failed stability specifications.
Perrigo New York is recalling 571,632 tubes of Hydrocortisone Ointment 2.5% because the product failed stability specifications.
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.
Milbar Laboratories is voluntarily recalling 14,491 tubes of MD Complete Clarifying Cleanser due to Good Manufacturing Practice (GMP) deviations.
Prescript Pharmaceuticals is recalling Clindamycin 300 mg capsules because the storage temperature label differs from the manufacturer's original declaration.
Milbar Laboratories is recalling 2,156 tubes of Solar Defense Sheer Sunscreen SPF50 due to Good Manufacturing Practice (GMP) deviations.