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.
LeMaitre Vascular is recalling one Artegraft Collagen Vascular Graft that was incorrectly packed in outer packaging labeled for a different size.
Sedecal is recalling eight SM-32HF-B-D-C 32KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg across several lots after routine stability testing returned an out-of-specification result for highest unknown impurity.
Sedecal is recalling 10 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.
Sedecal is recalling nine SM-40HF-Batt 40KW analog mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Church & Dwight is recalling 21,912 bottles of Zicam Medicated Fruit Drops Elderberry Flavor because the label failed to list elderberry as an ingredient.
Sedecal is recalling four SM-40HF-B-D-C 40KW 50C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
ibspot is recalling three boxes of Taoscare Motion Sickness Patches because the product was marketed without an approved new drug application.
UIH Technologies is recalling four uMI Panorama 35 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
Sedecal is recalling 27 SM-40HF-B-D-C 40KW 50G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
JB Chemicals is recalling 9,936 hundred-count bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.
JB Chemicals is recalling 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.
Sedecal is recalling one SM_40HF_BDC3 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 17 SM_40HF_B_D_VIR3 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one SM-40HF-B-D-C 40KW 70C EN mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling six SM-40HF-B-D-C 40KW.005 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 12 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.
Sedecal is recalling one 40KWMOBILE3.899 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling seven model 40KWFXPLUS-710CW.007 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
UIH Technologies is recalling eight uCT 530 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
Sedecal is recalling 55 model 40KWFX mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 14 SM-40HF-B-D-C 40KW 70C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
The Harvard Drug Group is recalling Gabapentin Capsules USP 100 mg in 10-capsule blister packs after routine stability testing returned an out-of-specification result for highest unknown impurity.
Sedecal is recalling one SM-40HF-B-D-C 40KW 55C/60C mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling three model 40KWFXPLUS.004 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.