Hazard
26 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 26 unapproved distribution 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 unapproved distribution 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.
MicroPort Orthopedics is recalling 91 units of the HIPTURN 36mm reusable femoral head trial because the product does not have FDA premarket authorization for US distribution.
Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
Acumed LLC is recalling 7,498 units of Dual-Trak Clavicle Screws distributed worldwide without FDA pre-market clearance. These orthopedic surgical screws were marketed without required regulatory approval.
LumiQuick Diagnostics is recalling Barbiturate Strips shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics Inc. is recalling Propoxyphene Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Methadone Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling Oxycodone Strips because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Salmonella typhi/paratyphi Antigen Tests because they were shipped to locations without FDA approval.
LumiQuick Diagnostics is recalling Methylphenidate Test Strips because they were shipped to locations without required FDA clearances.
LumiQuick Diagnostics is recalling all lots of its Rotavirus Test Card because they were shipped to US locations without approved FDA clearance.
LumiQuick Diagnostics is recalling EDDP Test Cards because they were shipped to locations without required FDA approvals.
LumiQuick Diagnostics Inc. is recalling Buprenorphine Test Strips because they were shipped to locations without FDA approval.
LumiQuick Diagnostics is recalling Morphine Strips (2000) because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling all lots of its Ketamine Strip because the products were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling all lots of the Ketamine Test Card because they were shipped to US locations without required FDA clearance.
LumiQuick Diagnostics is recalling Tramadol Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling Oxycodone Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling Fentanyl Test Cards because they were shipped to US locations without required FDA approvals.
LumiQuick Diagnostics is recalling H. Pylori Antigen Test Cards because they were shipped to locations without required FDA clearance.
LumiQuick Diagnostics Inc. is recalling PCP Test Strips distributed to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling PSA Test Cards shipped to US locations without approved PMA, IDE, or 510(k) clearance.
LumiQuick Diagnostics is recalling K2 Test Strips because they were shipped to locations without FDA clearance.