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.
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
Baxter Healthcare is recalling five Prismaflex Control Units distributed to Puerto Rico and Guam because they lack FDA regulatory clearance.
Butterfly Network, Inc. is recalling 11,183 Butterfly iQ Ultrasound Systems because they were distributed without an approved 510(k).
Polymer Technology Systems is recalling PTS Detect Cotinine in vitro diagnostic devices due to a lack of FDA 510(k) clearance.
Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.
Abbott Point of Care is recalling i-STAT G3+ blue cartridges because it lacks sufficient clinical evidence to characterize their performance.
Edan Diagnostics is recalling 7 iT20 telemetry transmitters because they include a function not cleared by the U.S. FDA.
Abbott Point Of Care Inc. is recalling i-STAT CG4+ cartridges because they are not FDA cleared and lack CLIA waived status.
Pentax of America Inc is recalling specific Pentax Video Colonoscopes because they were distributed in the USA without an approved 510K.
Pentax of America Inc is recalling one unit of the EC38-i10L Video Colonoscope because it was distributed in the USA without an approved 510(k).
Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.
Pacific Medical Group is recalling 772 fetal transducers distributed in the U.S. and abroad before receiving required FDA 510(k) and international clearances.
Pacific Medical Group Inc. is recalling 261 fetal transducers distributed in the U.S. and abroad before receiving required FDA and international clearances.
Pacific Medical Group Inc. is recalling 225 ultrasound transducers distributed before receiving required FDA and international clearances.
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound units because fetal transducers were distributed before receiving required FDA and international clearances.
Pacific Medical Group Inc. is recalling 678 fetal ultrasound transducers because they were distributed before receiving required FDA 510(k) and international clearances.
Pacific Medical Group Inc. is recalling GE Corometrics Nautilus Ultrasound Transducers because they were distributed before receiving required FDA 510(k) and international clearances.
Caire, Inc. is recalling four European version FreeStyle Comfort Oxygen Concentrators because they were not cleared for use in the US.
Aerolase Corporation is recalling 649 LightPod Neo Lasers nationwide because they lack a required remote interlock connector.
Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
K2M, Inc. is recalling 503 Special Connector Instruments because they were developed without adequate consideration for a new regulatory filing.
Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.
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 product design change lacked proper FDA premarket clearance.