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.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling the MediPress pneumatic compression system because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Compass Health Brands is recalling MediPress pneumatic compression systems because a design change lacked proper FDA premarket clearance.
Bound Tree Medical is recalling 747 Curaplex Epi Safe Kits because they are incorrectly labeled with an expiration date of May 2018 instead of May 2019, and the syringe component lacks 510(k) clearance.
Clark Laboratories is recalling 14 ultra2 Genesys Variants Analyzer devices because they lack FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.
Clark Laboratories is recalling 216 units of Genesys 2 Reagent because the product lacks the required FDA 510(k) clearance for marketing.
Clark Laboratories is recalling 252 units of Genesys 1 Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and has been terminated.
Clark Laboratories is recalling 463 units of Genesys Diluent Reagent because the product lacks FDA 510(k) clearance. The recall is voluntary and affects in vitro diagnostic use.
Clark Laboratories, Inc. is voluntarily recalling 372 Genesys Analytical Columns because they were distributed without FDA 510(k) clearance.
Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).
Medtech SAS is recalling 29 ROSA Robotized Stereotactic Assistant units because they lack an updated device approval.
Lupin Pharmaceuticals is recalling My Way emergency contraception tablets because the 2-pack configuration was marketed without the required regulatory approval.
Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Straumann Manufacturing is recalling Emdogain 0.7 ml Multipacks because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Ondamed Inc is recalling 585 Ondamed Biofeedback Devices because they were marketed in the US without FDA clearance. Customers are advised to contact the firm for an available upgrade.
Heidelberg Engineering is recalling the Widefield OCT software feature for Spectralis HRA+OCT devices because FDA determined a 510(k) clearance is required before use.
Mindray DS USA is recalling 1,719 Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Laerdal Medical Corporation is recalling 204 LCSU 4 suction units that were refused entry into the U.S. by the FDA because they lacked necessary CDRH approvals.
Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA premarket notification clearance.
Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.