Hazard
91 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 91 regulatory violation recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 43 (47%) 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 violation 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.
The One Step P in vitro diagnostic test (REF 8194) was distributed without required FDA premarket clearance or approval. The manufacturer DFI Co., Ltd. is recalling the device.
DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.
DFI Co., Ltd. is recalling One Step K in vitro diagnostic test devices (761 units) because they were distributed without required FDA premarket clearance or approval.
Cucumber Mint Lemonade is being recalled because the firm manufactured and distributed unpasteurized juice products to retailers in violation of the Juice HACCP regulations. 2,554 bags are affected.
Green Reviver Juice is being recalled because the firm manufactured and distributed unpasteurized juice products to retailers in violation of the Juice HACCP regulations. 1,932 bags are affected.
King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.
King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.
Beberoadlove is recalling about 1,940 New Moon Travel Bassinets because they lack a required stand and can fall from elevated surfaces, violating federal safety regulations for infant sleep products. No injuries have been reported.
Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.
Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.
Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.
Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.
Stateside Bead Supply is recalling high-powered 5mm magnetic beads sold online from November 2022 through June 2023 because they violate federal magnet safety regulations and pose an ingestion hazard. If swallowed, the magnets can lodge in the digestive system and cause serious injury or death.
Zeus Scientific is recalling 296 ZEUS ELISA Parvovirus B19 IgG Test System kits distributed in seven US states because an unapproved modification was made to the test reagent without FDA approval.
Moonsea Pack and Play Mattresses sold on Amazon violate federal crib mattress safety regulations and pose a suffocation hazard to infants. Consumers should stop using them immediately and contact Moonseasleep for a refund.
BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.
Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.
SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.
Able Groupe Inc is recalling Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula because some products contain insufficient iron and lack required FDA labeling. The formula may not provide adequate iron for certain infants, including premature infants and those with low birth weight.
Able Groupe Inc is recalling Holle Goat Stage 1 Organic Infant Milk Formula because required FDA pre-market notifications were not submitted and products lack mandatory labeling statements in English.
Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.
Confirm Biosciences is recalling Orient Gene COVID-19 Rapid Test Cassettes because they were distributed outside Emergency Use Authorization and not validated for fingerstick use.
Aesthetics Biomedical is recalling 623 Vivace Electrosurgical Systems because a high-frequency output was not cleared for U.S. distribution.