Hazard
1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 device malfunction 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.
B. Braun Medical is recalling 200 units of Con Epi Trays because damage to the filter membrane prevents the device from achieving its required filter capacity.
Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.
Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.
MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.
Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.
Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.
Inovo, Inc. is recalling 690 Single Luman Conservers because the pressure gauge may dislodge from the mount, creating a leak.
Bard Peripheral Vascular is recalling specific Nautilus Delta Port Kits due to a risk of losing the intravascular ECG signal during placement procedures.
CooperSurgical is recalling LEEP Precision Integrated Systems because the foot pedal may fail to operate the cut, coagulate, or blend functions.
Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.
Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes because some may be assembled incorrectly, preventing the delivery of defibrillation or pacing therapy.
Cardiocommand Inc. is recalling five units of its Transesophageal Cardiac Pacing and Recording System, Model 7A, due to possible corrosion of the battery contacts.
Flowonix Medical Inc is recalling 6,445 Prometra II Programmable Pumps because a software defect can cause the device to shut down unexpectedly.
Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small. The affected units were distributed domestically and internationally.
Flowonix Medical Inc is recalling 40 units of Prometra Programmer software due to a defect that causes intrathecal pumps to shut down unexpectedly.
Flowonix Medical Inc. is recalling 809 Prometra Programmable Pumps because a software defect can cause the pump to shut down unexpectedly.
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
Boston Scientific is recalling 27 Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause the device to stop emitting laser pulses during surgery.
Thommen Medical AG is recalling 15 units of dental adapters for handpieces because the coupling may deform, making removal difficult.
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.
Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH25A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Ethicon Endo-Surgery is recalling Curved Intraluminal Staplers, Model CDH25A, because they may have an insufficient firing stroke to break the washer and completely form staples.
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH33A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Moller Vital is recalling Molift 2-Point sling bars because broken hooks may cause the sling to slip and patients to fall.