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 one SM-20HF-Batt 20KW analog mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant and must be cleaned strictly per the manual.
Graviti Pharmaceuticals is recalling 46,512 bottles of Bupropion Hydrochloride Extended-Release Tablets USP (XL) 300 mg from one batch for failed tablet specifications.
UIH Technologies is recalling 11 uCT 760 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
Synthes is recalling 122 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.
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.
Sedecal is recalling one 40KW-FX.899 mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
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.
UIH Technologies is recalling two uCT ATLAS computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.
ibspot is recalling three boxes of Taoscare Motion Sickness Patches because the product was marketed without an approved new drug application.
Sedecal is recalling eight model 40KWFXPLUS.002 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
Lannett is recalling 46,848 bottles of Niacin Extended-release Tablets USP 1,000 mg across several lots for failed dissolution specifications.
Sedecal is recalling six SM-40HF-B-D-C 40KW.002 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.
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 five SM-40HF-B-D-C 40KW 55C mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
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 six SM-40HF-B-D-C 40KW 80C 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 the SED URS LP mobile X-ray system, serial 40116, after emailing consignees to remind users that the equipment is not water-resistant.
Sedecal is recalling one SM_40HF_BDC mobile X-ray system after emailing consignees to remind users that the equipment is not water-resistant.
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 one SM-40HF-B-D-C 40KW 55C mobile X-ray system, serial G37528, 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.
UIH Technologies is recalling 22 uCT 550 computed tomography systems because third-party outer covers can become trapped between the patient table and gantry.