Hazard
47 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 47 sterile barrier failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (6%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile barrier 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.
Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity.
Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits because packaging may not consistently maintain sterile barrier integrity.
Medical Action Industries is recalling blood culture kits containing BD ChloraPrep applicators with potentially compromised sterile seals, posing a risk of localized skin infection.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401904) due to incomplete seals on sterile product. The recall affects 1,352 units distributed across the United States, Israel, and Canada.
Galt Medical Corporation is recalling B Braun Interventional Coaxial Dilator Micro-Introducer Kits due to a potential open seal in the sterile barrier packaging. The affected kits are distributed nationwide in eight U.S. states and six countries.
Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.
Medtronic is recalling 500 units of Clearview Blower/Mister Model 22120 due to potential for unsealed sterile packing that could compromise device sterility.
Exactech is recalling 1,970 Equinoxe Reverse Shoulder humeral liners distributed nationwide and internationally due to nonconforming packaging that lacks required oxygen barrier protection. Affected devices may have compromised sterile barriers.
Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.
Medtronic is recalling 77 units of Grafton DBM (Flex) due to a potential failure to perform required inspection of the outer Tyvek sterile pouch. Affected units may not meet sterile packaging standards.
Medline is recalling probe cover kits used in cardiac and vascular ultrasound procedures due to inadequate seam barriers. Over 3.7 million units were distributed worldwide from December 2017 through May 2023.
Medtronic is recalling 2,317 RadiaLux Lighted Retractor units due to defects in the sterile pouch seal that increase contamination risk and potential post-operative infection.
NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.
Medline has recalled Bausch + Lomb cataract surgical kits due to breather pouches with seal openings that could compromise sterility. Affected kits were distributed nationwide.
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failure that could compromise the sterile barrier. The recall affects 602,340 units distributed worldwide.
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.
Baxter is recalling DISCPAC Syringe Tip Caps due to potential packaging defect that may not maintain sterile barrier. The recall affects 8,500 units distributed worldwide.
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging defects that may not maintain sterile barriers. The recall affects approximately 63,190 units distributed worldwide.
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.
Xodus Medical Inc is recalling 255,000 Cautery Tip Cleaners because the sterile barrier of some devices may have been affected.
Xodus Medical Inc is recalling 460,000 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.
BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x30 due to a manufacturing flaw in the sterile barrier system.
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x120 due to a manufacturing flaw in the sterile barrier system.
Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.
Zimmer Biomet is recalling 11 trauma guide wires due to packaging defects that may compromise sterility, posing an infection risk.