Hazard
2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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 compromise 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.
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.
Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
Hospira is recalling 603,768 bags of 0.9% Sodium Chloride Injection because solution leaked through the port cover, compromising sterility.
Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.
Zimmer, Inc. is recalling ZIMTRON 6 DEG 22 Heads because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling HGP II Acetabular Cup Mod units because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 3.5 compression plates sterile packaged at its Puerto Rico facility because packaging operations were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7 million sterile orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling Versys femoral stems because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer, Inc. is recalling 7,044,680 self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer is recalling 7,044,680 Asia One-Piece Lag Screws because packaging operations at a Puerto Rico facility were not properly validated, potentially affecting sterile barrier integrity.
Zimmer is recalling interlocking IM screws and tibial nails sterile packaged at a Puerto Rico facility because packaging operations were not properly validated.
Zimmer is recalling specific Versa-FX orthopedic implant lots because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Trilogy Acet Shell and Bone Screw devices due to unvalidated packaging operations at its Puerto Rico facility.
Zimmer is recalling 12/14 femoral heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling Interlocking IM Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.
Zimmer is recalling 7,044,680 orthopedic screws because packaging operations at its Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
Zimmer, Inc. is recalling 7,044,680 units of Pressfit Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated.
Zimmer is recalling FEM HD ION hip implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling specific sterile orthopedic screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling Magna-Fx Cannulated Screw Fixation Systems because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.