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.
Wilson-Cook Medical is recalling 8 units of Captura Serrated Biopsy Forceps in France, Ireland, and Japan due to mislabeling.
Wilson-Cook Medical is recalling 6 units of Captura Serrated Forceps due to mislabeling that swapped spike and no-spike models.
Advanced Pharma Inc. is recalling Heparin Injectable Solution because the label incorrectly states the concentration as 50 mg/50 mL instead of 50 Units/50 mL.
Stryker is recalling 103 reprocessed diagnostic electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.
Lupin Pharmaceuticals is recalling 24,180 bottles of Fluocinolone Acetonide Topical Solution due to elevated impurities.
Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT HS tablets due to sub-potency and cGMP violations. The product was distributed nationwide.
Lupin Pharmaceuticals is recalling 7,215 bottles of Cephalexin for Oral Suspension because the manufacturing batch record could not be located.
Waldemar Link is recalling 30 BiMobile UHMWPE Liners because internal labeling may contain incorrect part numbers, risking errors in patient records.
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
Ethicon is recalling 840 units of PERMA-HAND Silk Sutures because the product inside the packaging does not match the size or type indicated on the label.
Arrow International Inc. is recalling specific lots of pediatric central venous catheters because the lidstock labels list incorrect priming volumes and flow rates.
Teva Pharmaceuticals USA is recalling specific lots of Olmesartan Medoxomil and Hydrochlorothiazide Tablets because they failed to meet dissolution specifications.
Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.
Waldemar Link is recalling 31 BiMobile UHMWPE Liners because internal labels may contain incorrect part numbers, risking errors in patient records.
Syntho Pharmaceuticals is recalling 5,000 bottles of EEMT tablets because they were found to be sub-potent and involved cGMP violations.
Canadian Hospital Specialties is recalling 750 pediatric polyurethane feeding tubes because they may be packaged with a 5FR tube instead of the labeled 6.5FR size.
DeRoyal Industries is recalling 200 Enteral Safe Feed Tubes labeled as 6.5 FR but containing 5 FR tubes. The recall covers units distributed to Texas and Utah.
Bound Tree Medical is recalling 84 Curaplex Epi Safe Administration and Training Kits because the epinephrine vials inside expired in December 2018, despite the outer label showing January 2020.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to product complaints indicating the reconstituted suspension was observed to be thick.
GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because customer complaints reported a malfunctioning plunger on the applicator delivery system.
Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.
Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.
Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the physical screw lengths do not match the labels.