Hazard
123 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 123 sterile barrier compromise recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (1%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile barrier 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.
Centurion Medical Products Corporation is recalling 3,250 Daily Driveline Kits because the sterile packaging may be compromised, posing a risk of infection.
CIVCO Medical Instruments is recalling SonoSite L25 Bracket Kits because the needle guide bracket may puncture the sterile cover during assembly.
Stryker is recalling 22,831 AXS PP cranium plates because the sterile packaging may become compromised after three years.
Stryker is recalling QUIKFLAP cranial plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker Leibinger is recalling QUIKFLAP cranium plates because the sterile packaging may become compromised after three years, potentially affecting sterility.
Stryker is recalling QUIKFLAP burr hole covers because the sterile packaging may become compromised after three years.
Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.
Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.
Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.
Merit Medical Systems is voluntarily recalling 178 Fluid Management Sets due to a compromised sterile barrier.
Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) because the included Medtronic Kerlix sponges may have compromised sterile barriers.
Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.
Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture the sterile barrier.
Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.
Stryker is recalling specific wrist implant models because their sterile packaging may be compromised during transportation.
Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.
Zimmer GmbH is recalling 10,340 BIOLOX delta Ceramic Femoral Heads due to potential sterile tray compromise, which could lead to periprosthetic infection.
Zimmer GmbH is recalling 1,908 CoCr Femoral Heads due to potential sterile tray compromise. Undetected breaches could lead to contamination and periprosthetic infection.
Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.
Zimmer is recalling 6 Degree COCR Femoral Heads because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Zimmer is recalling 7,044,680 humeral intramedullary nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
Applied Medical is voluntarily recalling Inzii Tissue Retrieval Bags because packaging punctures could compromise the sterile barrier, posing a theoretical risk to patients.