Hazard
12 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 12 regulatory clearance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all regulatory clearance 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.
Covidien Mon-a-Therm General Purpose Temperature Probes, REF 90044, are being recalled because the devices lack FDA clearance. 1,775 units are affected.
Covidien Mon-a-Therm general purpose temperature probes in size 9 Fr, REF 90050, are being recalled because the devices lack FDA clearance. 128,900 units are affected.
Covidien Mon-a-Therm Esophageal Stethoscopes with Temperature Sensor 400TM, REF 90042, are being recalled because the devices lack FDA clearance. 23,000 units are affected.
Medline is recalling a range of custom left heart and catheterization kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.
Medline is recalling convenience kits containing select 10 mL polycarbonate colored syringes because of unapproved design changes made outside the 510(k) clearance. 270,311 units are affected.
i-STAT CG8+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 8,962,450 units are affected.
i-STAT CG4+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting the updated lactate sample type and pH and PO2 measurement ranges. 9,067,050 units are affected.
i-STAT EG7+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 6,115,950 units are affected.
i-STAT EG6+ cartridges are recalled across all lots for lack of a 510(k) premarket clearance reflecting updated sample types and measurement ranges. 547,250 units are affected.
ReQuest Measles IgM ELISA kits, catalog number 01-190M, are recalled because the test kit lacks premarket approval or clearance. 376 kits are affected.
Blood Uric Acid Monitoring System kits, model eB-U01, are recalled because the products were distributed without premarket clearance or approvals. 2,240 units are affected.
A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.