Hazard
462 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 462 sterility breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (5%) 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 sterility breach 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.
Globus Medical is recalling Cranial Drill 6.00mm units due to potential packaging breaches that may render the sterile product non-sterile, and discoloration near the drill tip.
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
B. Braun Medical Inc. is recalling 79,880 bags of Sodium Chloride Injection due to potential leakage that could compromise sterility. No illnesses or injuries have been reported.
DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.
DeRoyal Industries is recalling 3 packs of Pelvic Exam Trays because the outer package seals may be open or compromised, potentially affecting the sterility of the medical procedure packs.
C.R. Bard Inc is recalling Magic3 Go pediatric intermittent urinary catheters due to a manufacturing defect where the resealing label can separate from the foil pouch, potentially compromising product sterility.
Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.
Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.
Medline is recalling surgical convenience kits because the perforated bag does not maintain sterility of the kit's exterior wrapping. Only the contents inside the wrapping are sterile.
Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.
Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.
Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.
Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.
Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.
Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.