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.
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 55 model 40KWFX mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling six SM-40HF-B-D-C 40KW Canon Ready mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 24 RadPro Mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling four SM-40HF-B-D-C 40KW 55C/60C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
UIH Technologies is recalling 11 uCT 760 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
Sedecal is recalling eight model 40KWFXPLUS.002 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
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.
Sedecal is recalling three SM_40HF_B_D_VIR3.004 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 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 17 SM_40HF_B_D_VIR3 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 six 40KW70CDEMO.005 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 Canon Ready mobile X-ray system, serial G41234, after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 268 model 40KWFXPLUS mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling 56 SM-40HF-B-D-KM (AeroDR X30) mobile digital diagnostic X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
JB Chemicals is recalling 13,440 bottles of Cetirizine Hydrochloride Tablets USP 10 mg because the tablets were imprinted with the wrong identification code.
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.
UIH Technologies is recalling two uCT ATLAS computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
Sedecal is recalling eight Easy Moving Plus SM-50HF-B-D-C 50KW 50G mobile X-ray systems 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.
Sedecal is recalling five SM-40HF-B-D-C 40KW 55G mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
UIH Technologies is recalling two uCT 780 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.