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-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 39 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 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.
UIH Technologies is recalling three uMI 780 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
CPM Medical Consultants is updating the Fuse ULTRA Foot Plating System instructions for use to remove a sterilization option that does not apply in the United States.
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.
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 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 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 142 SM-40HF-B-D-C 40KW mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.
UIH Technologies is recalling two uEXPLORER PET/CT systems because third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference.
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.
UIH Technologies is recalling 95 uMI 550 PET/CT systems because third-party outer covers can become trapped between the patient table and gantry.
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.
Jayco is recalling certain 2025-2026 Entegra Condor and Jayco Granite Ridge motorhomes because the certification label may have the front and rear axle information reversed.
Glenmark is recalling 26,928 packs of Viorele desogestrel and ethinyl estradiol tablets from one batch after the product failed impurities and degradation specifications.
STAQ Pharma is recalling one lot of Hydromorphone HCL PF 10mg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.
STAQ Pharma is recalling three lots of FentaNYL Citrate PF 500mcg/50 mL injection syringes because of incorrect or missing lot and expiration date information on the label.
Ascend Laboratories is recalling 141,984 bottles of Atorvastatin Calcium Tablets USP 10 mg for failed dissolution specifications.
Tropicana Brands Group is recalling 1,599 cases of Dole Apple Juice in 15.2 fl oz bottles after a manufacturing process deviation that may cause spoilage or microbial contamination.
Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.
Viona Pharmaceuticals is recalling 13,080 bottles of Tavaborole Topical Solution 5% across three lots because of discoloration.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 40 mg for failed dissolution specifications.
Endo USA is recalling 1,041 cartons of Everolimus tablets 5mg after the lot returned an out-of-specification result for impurity IP-C.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 20 mg for failed dissolution specifications.