Hazard
12 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 12 hardware defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (25%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all hardware defect 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.
Automated Impella Controllers that have not been through Abiomed's servicing process are pending four hardware updates addressing motor control, startup and pump stop risks.
Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.
Datascope Corp. is recalling approximately 9,175 Cardiosave Rescue IABPs because unexpected gas-loss and gas-gain alarms may occur during therapy due to patient movement, blood in the circuit, and hardware issues.
Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.
Hitachi Healthcare is recalling 120 Model L43K intraoperative probes because the screw cover at the probe tip may fall off after cleaning and sterilization. Facilities should inspect probes before and after sterilization and before and after each surgical use.
Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.
Siemens Medical Solutions is recalling 605 Artis Q. angiography systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
Philips is recalling 13,168 HeartStart XL+ defibrillators worldwide due to software and hardware issues that can affect device function.
Philips Medical Systems is recalling 33 Ingenia 1.5T MRI systems because incorrect M10 nuts were installed on the rear cover set.
GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
GE OEC Medical Systems is recalling OEC MiniView 6800 Mobile C-Arms due to a hard disk drive issue. The recall covers 82 units distributed worldwide.
GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.