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.
Medline Industries is recalling Suture Removal Kits because the iodine concentration is below the label claim of 0.85%.
Medline Industries is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
A&H Focal Inc. is recalling Hard Ten Days capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling MACA gold tablets sold in New York and New Jersey because they contain sildenafil, an unapproved drug.
Medline Industries is recalling Abdominal Surgery II Packs because the iodine content in the prep pads is below the label claim.
Medline Industries is recalling Skin Stapler RMVR trays because the iodine concentration in the prep pads is below the labeled claim.
Medline is recalling Incision and Drainage Trays because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Vitrectomy CDS Packs because the iodine concentration is below the label claim of 0.85%.
Medline Industries is recalling Debridement Trays because the iodine concentration in the prep pads is below the label claim.
Medline Industries is recalling Suture Removal Trays because the iodine content in the prep pads is below the labeled claim.
Stryker is recalling Mistral-Air Premium Blankets because they may conduct electricity during high-energy defibrillation if applied upside down.
Medline Industries is recalling sterile Povidone-Iodine prep pads because the iodine content is below the label claim of 0.85%.
A&H Focal Inc. is recalling STREE OVERLORD capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Medline Industries is recalling Skin Staple Remover Kits because the iodine content is below the label claim of 0.85%.
A&H Focal Inc. is recalling LIEN CHAN FOR SEVEN DAYS capsules because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
Medline Industries is recalling Concordia Trunk 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 claim of 0.85%.
Medline Industries is recalling sterile catheter insertion kits because the iodine concentration in the prep pads is below the labeled claim.
A&H Focal Inc. is recalling Yanshijiaonang capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
Medline is recalling Suture Removal Trays because the Povidone-Iodine prep pads contain less iodine than the label claims.
Medline Industries is recalling 700 cases of Suture Removal Trays because the iodine concentration is below the label claim.
A&H Focal Inc. is recalling Black Ant capsules found to contain sildenafil, an unapproved drug with unestablished safety and efficacy.
A&H Focal Inc. is recalling Miraculous Evil Root capsules because FDA analysis found they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
Medline Industries is recalling Pacemaker Implant Packs because the Povidone-Iodine prep pads contain less iodine than labeled.
Medline Industries is recalling Suture Removal Packs because the iodine content is below the label claim of 0.85%.