Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
A&H Focal Inc. is recalling MAX MAN capsules sold in New York and New Jersey because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
Medline Industries is recalling RAD NECK ENT TRAY packs because the Povidone-Iodine prep pads contain subpotent iodine levels below the label claim.
Medline Industries is recalling sterile staple remover kits because the iodine concentration is below the labeled claim.
Medline Industries is recalling 73 cases of Incision & Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Baxter Healthcare is recalling Nexterone (amiodarone HCl) Premixed Injection because polyethylene particulate matter was identified in the product packaging.
Medline Industries is recalling Suture Removal Trays because the iodine concentration in the prep pads is below the labeled claim.
Medline is recalling 1,100 cases of GHS Suture Removal Trays because the iodine concentration is below the label claim.
Medline Industries is recalling hip replacement kits containing Povidone-Iodine prep pads with iodine levels below the label claim of 0.85%.
Medline Industries is recalling lidded catheter care trays because the povidone-iodine prep pads contain less iodine than the label claims.
A&H Focal Inc. is recalling Germany Niubian tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Medline is recalling sterile incision and drainage trays because the povidone-iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.
A&H Focal Inc. is recalling Ye Lang Shen capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Medline Industries is recalling 51 cases of Concordia Nurse Bag Kits because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the labeled 0.85% claim.
Medline Industries is recalling 600 cases of Laceration Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling 231 cases of Trunk Kits because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the labeled claim of 0.85%.
Medline Industries is recalling Povidone-Iodine prep pads because the iodine content is below the labeled claim of 0.85%.
A&H Focal Inc. is recalling Germany Black Gold tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.
Medline Industries is recalling Vaginal Delivery CDS Packs because the iodine content is below the label claim.
Medline Industries is recalling Suture Removal Trays because the iodine concentration is below the labeled claim.
A&H Focal Inc. is recalling Gold Vigra capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.