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 126 shoulder packs used for wound care due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 270 units of Shoulder Arthroscopy Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Oasis Brands is voluntarily recalling Lacteos Santa Martha Crema Nica after Listeria monocytogenes was detected in related products and environmental samples.
Oasis Brands is voluntarily recalling Lacteos Santa Martha cream products after Listeria monocytogenes was detected in related products and environmental samples.
Customed, Inc. is recalling 680 General Minor Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 120 Arthoscopy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 36 breast packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Utility Drape End Products due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling Premium Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Customed, Inc. is recalling 1,140 cataract 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 lead to patient infection.
Customed, Inc. is recalling 840 Major Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 354 Pery GYN Surgical Packs because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 71 Open Heart Trays due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 240 impervious gowns due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling Skin Staple Removal devices (Catalog 900-782) because compromised sterility and manufacturing deficiencies may result in patient infection.
Customed, Inc. is recalling 335 Premium OB Packs because compromised sterility and inadequate storage conditions may result in patient infection.
Customed, Inc. is recalling 654 Cesarean Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Customed, Inc. is recalling 122 C-Section Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Ameritrans is recalling 2013-2014 F330 and 2013 R330 transit buses because a suspension fluid tank mount may fail, causing the tank to separate and create a road hazard.
Customed, Inc. is recalling Wound Management Tray III units because compromised sterility and manufacturing deficiencies may result in patient infection.
Hyundai is recalling specific 2015 Sonata vehicles because an incorrect left axle shaft may separate from the transaxle, potentially causing the vehicle to stop moving or roll away.
Cummins is recalling specific Ecofit Tier2 DOC raincaps because the lid may detach, posing a crash or injury risk.