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.
Customed, Inc. is recalling 1,500 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 9,770 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 440 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling surgical gowns due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 204 Transverse Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 80 OB Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 352 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 260 Cesarean Packs (Catalog 900-410) due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling Wound Management Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 344 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 1,120 units of Gown Fabric Reinforced XXL due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 57 Laparoscopy Packs (Catalog 900-1967) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 108 D&C Laparoscopy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 380 Cysto Tur Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 96 Shoulder Packs (catalog #900-2616) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 340 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 160 Higado & Pancrea Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 40 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 126 Cesarean Packs because compromised sterility and inadequate storage conditions may result in patient infection.