Hazard
574 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 574 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 34 (6%) 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.
Cook Inc. is recalling 629 StoneBreaker Exhaust Caps because the interior may not be sterilized to the appropriate level when following reprocessing instructions.
Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.
Zimmer GmbH is recalling Normed Charcot Osteotome Chisels because a gap between the handle and metal chisel may prevent proper disinfection or sterilization between uses.
Zimmer Biomet is recalling 14,461 TunneLoc Tibial Fixation Devices because gamma sterilization testing suggests the sterilization dose may be inadequate.
Zimmer Biomet is recalling TunneLoc Tibial Fixation Devices because testing suggests the sterilization dose may be inadequate. The devices are distributed nationwide.
AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.
Cosman Medical is recalling Nitinol TC Reusable Electrodes because epoxy damage after reprocessing can prevent the removal of blood and tissue residuals.
Medline Industries is recalling 190 units of pediatric elbow closed suction catheters because they were distributed before being sterilized.
Becton Dickinson is recalling 547,600 units of BD 10mL Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.
O-Two Medical Technologies is voluntarily recalling specific lots of Burn Relief hydrogel dressings because there is a lack of evidence validating the sterilization dose, posing a potential contamination risk.
Molnlycke Health Care is recalling 956 units of the Brennen Skin Graft Mesher because of a sterilization validation failure. The instruments were distributed domestically and internationally.
Customed, Inc. is recalling 15 units of Plastic Surgery Packs (Catalog Number 9001402) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 18 units of Hip and Knee Replacement Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Customed, Inc. is recalling 30 units of Laparoscopic Gynecology Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 576 cataract surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 220 units of Premium Obstetrical Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 42 Laminectomy Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Customed, Inc. is recalling 16 units of Femoral Angiography Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 16 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 30 units of Basic Surgical Pack IV in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 25 units of Urology Surgical Packs (Catalog No. 9001738) due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 72 Cysto TUR Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Customed, Inc. is recalling 5,650 Suction Catheter Trays 14FR with Sodium Chloride 0.9% Irrigation because of inadequate validation of sterilization processes and package integrity.