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 120 OB Packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 105 Laparoscopy OB GYN Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 207 Neuro Spine Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 96 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 76 Cesarean Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Tracheotomy Care Kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 129 medical devices due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 106 Open Heart Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 70 Angiography Packs (Catalog 900-1488) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 600 C-Section Surgical Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 168 Extremity PACKs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Wound Closure Tray II units due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 156 Laparoscopy Packs (Catalog 900-1176) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 264 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 372 Laparotomy Packs (Catalog # 900-996) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling six Total Hysterectomy kits due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 240 Laparoscopy Packs (Catalog 900-474) due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 60 Urology Packs (Catalog 900-1742) because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 160 Open Heart Trays (Catalog 900-170) due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Customed, Inc. is recalling 162 units of Peri Gyn Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 180 units of Peri Gyn Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 176 D&C Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 40 Urology Packs (Catalog 900-1738) due to compromised sterility and inadequate storage conditions that may result in patient infection.
Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.