Hazard
536 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 536 regulatory non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 56 (10%) 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 regulatory non compliance 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.
Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.
Aesculap Implant Systems LLC is recalling 292 units of the JS Series SterilContainer S2 System because they were released to the market before receiving authorized FDA 510K clearance.
Aesculap Implant Systems LLC is recalling ELAN 4 Burr accessories because they were marketed without 510(k) premarket notification clearance.
Jubilant Cadista Pharmaceuticals is recalling 744 bottles of Meclizine Hydrochloride 12.5 mg tablets because they were released prior to final approval.
Optovue is recalling 326 iVue 500 devices because FDA determined a 510(k) is needed for the Vault Mapping software.
Optovue is recalling 326 iFusion and iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.
Optovue is recalling 326 iVue devices because FDA determined a 510(k) is needed for the Vault Mapping software.
Natus Medical is recalling Olympic Pasteurmatic 3000 and 3500 systems because they do not fully meet current regulatory requirements due to design age and component obsolescence.
3CS Organics LLC is recalling HIPP infant formula products because they are not FDA approved and lack full English labeling.
3CS Organics LLC is recalling specific Lebenswert infant and toddler milk formulas because the products are not FDA approved and lack full English labeling.
3CS ORGANICS LLC is recalling HIPP Anti-Reflux AR Bio-Spezialnahrung because the product is not FDA approved and lacks complete English labeling.
Sterilmed is recalling 963 reprocessed EP ablation cables because they are Class III devices that lack required premarket approval.
Vinh Hoan USA is recalling approximately 84,000 pounds of frozen Swai fillets that entered U.S. commerce without meeting federal import requirements.
Med-Hot Thermal Imaging, Inc. is recalling 12 units of the MTI 2000 Thermal Imaging System because the indications for use are not cleared or approved for the U.S. market.
Agilent Technologies is recalling Bond Elut OMS cards because they were marketed without the required FDA 510(k) clearance.
Focus Diagnostics is recalling Legionella IFA Substrate Slides because the device was found not to be 510(k) exempt.
Focus Diagnostics is recalling Legionella IFA devices because the company discovered the product is not 510(k) exempt. The recall affects 196 units distributed to three testing laboratories.
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy External Power Supply Units because they lack 510(k) clearance for a design modification.
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy devices because they lack 510(k) clearance for a design modification.
Sunset Natural Products Inc. is recalling Esclewe Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 2014.
Sunset Natural Products Inc. is recalling Abte bulk capsules pursuant to a consent decree requiring the destruction of dietary supplements manufactured since April 2014.
Sunset Natural Products Inc. is recalling Nem Dietary Supplement pursuant to a consent decree requiring the destruction of products manufactured since April 2014.
Sunset Natural Products Inc. is recalling Aloe Vera dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.
Sunset Natural Products Inc. is recalling Bionix dietary supplements pursuant to a consent decree requiring the destruction of products manufactured since April 2014.
Sunset Natural Products Inc. is recalling Murine bulk capsules pursuant to a consent decree requiring the destruction of supplements manufactured since April 2014.