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.
Stradis Healthcare is recalling Lima Pack surgical kits because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling 15 endovenous kits because they contain Devon Light Gloves, a component recalled by Medtronic.
American Health Packaging is recalling 5,591 cartons of Lisinopril 20mg tablets nationwide because the firm did not adequately investigate customer complaints.
Stradis Healthcare is recalling Custom Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.
American Health Packaging is recalling Amlodipine besylate tablets 5mg due to CGMP deviations involving inadequate investigation of customer complaints.
Siemens is recalling Dimension Vista Systems due to software issues that may cause samples to stop processing or deliver incorrect reagents, leading to unexpected test results.
3M is initiating a field correction to remove the crown indication from all Lava Ultimate products. The products remain indicated for onlays, inlays, and veneers.
Stradis Healthcare is recalling DND Packs containing Devon Light Gloves because the glove manufacturer, Medtronic, is recalling the component.
Apotex Inc. is recalling 4,584 bottles of Enalapril maleate and hydrochlorothiazide tablets, 10/25 mg, because the product may not meet blend uniformity specifications.
Stradis Healthcare is recalling breast augmentation kits because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
Stradis Healthcare is recalling Face Lift Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Lipo/Buttocks Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Suction Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
Apotex Inc. is recalling Losartan potassium tablets 25 mg because they may not meet blend uniformity specifications. The recall covers 45,708 bottles distributed nationwide, in Hawaii, and Puerto Rico.
Stradis Healthcare is recalling Cysto Packs because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.
American Health Packaging is recalling specific lots of Azithromycin tablets because the firm did not adequately investigate customer complaints.
American Health Packaging is recalling 838 cartons of Azithromycin 600mg tablets because the firm did not adequately investigate customer complaints.
Stradis Healthcare is recalling Phleb Packs and Laser Phleb Packs because they contain Devon Light Gloves that are subject to a separate manufacturer recall.
Stradis Healthcare is recalling Lipo Packs, Expended Packs, and Trays because they contain Devon Light Gloves that Medtronic is recalling.
American Health Packaging is recalling 2,068 cartons of Azithromycin tablets 250mg due to inadequate investigation of customer complaints.
Stradis Healthcare is recalling ENT Packs containing Devon Light Gloves due to a manufacturer recall of the glove component.
Stradis Healthcare is recalling Knee Arthro Packs because they contain a Devon Light Glove component that Medtronic is recalling.
Stradis Healthcare is recalling Plastic Packs containing Devon Light Gloves because the manufacturer, Medtronic, recalled the glove component.
Stradis Healthcare is recalling Orthopedic Split Drape Packs because they contain a Devon Light Glove component recalled by Medtronic.
Stradis Healthcare is recalling surgical convenience kits because they contain Devon Light Gloves that are subject to a separate recall by Medtronic.