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.
Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.
Time-Cap Laboratories is recalling specific bottles of Ibuprofen 200 mg caplets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Caplets 200 mg due to odor complaints and CGMP deficiencies. The recall covers nationwide distribution.
Time-Cap Laboratories is recalling specific lots of 800 mg ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because packaging design flaws may allow sterile barrier breaches.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 125II Assay kits because some patient samples may exhibit over-recovery outside the provided data.
Time-Cap Laboratories is recalling specific lots of ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Datascope is recalling 2,714 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use are missing the Contraindications section.
Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.
Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.
Terumo is recalling Sarns TCM II devices to update cleaning instructions. The recall covers 2,393 units distributed worldwide.
Terumo is recalling Sarns TCM devices to update cleaning instructions for the cooler-heater component.
TMJ Solutions Inc is recalling a specific right mandibular component of a TMJ Reconstruction Prosthesis System because it was mislabeled and is not the correct component for the intended patient.
Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.
AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, 100 mg, because the product failed dissolution specifications.
GE Healthcare is recalling Lunar DPX Duo and Bravo bone density scanners because a software issue may cause reports to be filed under the wrong patient name in the hospital system.
GE Healthcare is recalling 43 Lunar DPX bone density systems because patient reports may be sent to hospital systems with incorrect names in the header.
Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.
Swire Coca Cola is recalling 366 cases of Dr. Pepper Est. 1885 Diet, 20 FL Oz bottles due to the potential presence of foreign material.
Diamond Wipes International is recalling ACURE clarifying acne towelettes because they were manufactured with poor quality water.
Preservation Solutions, Inc. is recalling 31,104 units of Cold Storage Solution bags due to potential leaks at the injection port.
GE Healthcare is recalling Prodigy and Prodigy Advanced ultrasound systems because bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.
Noven Pharmaceuticals is recalling Daytrana (methylphenidate) transdermal patches because the adhesive transfer is out of specification.
Leadiant Biosciences is recalling 3,398 bottles of Cystaran ophthalmic solution because the active ingredient was below the required specification.
Diamond Wipes International is recalling WipeEssentials Wet Wipes because they were manufactured with poor quality water.