Hazard
580 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 580 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 38 (7%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterilization failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Customed, Inc. is recalling 80 units of Peri Gyn Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 16 units of Face Packs in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.
Customed, Inc. is recalling 24 units of Breast Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 960 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
American Medical Systems is recalling 16,710 Sureflex 910 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling 16,710 Sure F!ex reusable laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling Fiber Stripper tools because their cleaning and sterilization instructions do not meet FDA guidance for reusable medical devices.
American Medical Systems is recalling 16,710 Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
American Catheter Corp is recalling 890 Cholangiogram Catheters because they were not sealed before sterilization. The defect was not detected during acceptance or release activities.
American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.
American Medical Systems is recalling Sureflex 550 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.
American Medical Systems is recalling 16,710 Sure F!ex laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.