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 180 Laminectomy Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 460 Lithotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 70 Laparotomy Basic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling Suction Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 48 Cirugia Cardiovascular Case Carts due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 256 Arthroscopy Packs (Catalog 900-1062) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 230 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 246 units of Laparoscopy Chole Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Management Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 582 Ophthalmic Packs due to compromised sterility and inadequate storage conditions that may result in patient infection.
Customed, Inc. is recalling 1,050 Dressing Change kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 880 surgical packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 210 Angiography Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Mayo Stand Covers with CSR Wrap due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 92 units of Femoral Packs (catalog #900-2164) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 420 O.B. Packs (Catalog 900-645) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 2,520 surgical gowns because compromised sterility and inadequate storage conditions may increase the risk of patient infection.
Customed, Inc. is recalling 740 Peri Gyn Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 36 Hip Orthopedia Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 270 Femoral Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 185,000 surgical packs distributed in Florida, New York, and Puerto Rico because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 28 units of Laparoscopy Premium Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling specific lots of Surgeon Gown Poly Reinforced Lgc because compromised sterility and inadequate storage conditions may increase the risk of patient infection.
Customed, Inc. is recalling 490 Cesarean Packs (Catalog # 900-660) due to compromised sterility and manufacturing deficiencies that may result in patient infection.