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.
The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.
Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.
Biomerieux Inc is recalling PPM INDUSTRY COMBOURG BACARA culture plates because they were exposed to improper storage temperatures and duration. Product performance cannot be guaranteed under these conditions.
Biomerieux Inc. is recalling ETEST Clinical Ertapenem antibiotic susceptibility test strips after temperature and time excursions compromised product performance. Affected units cannot guarantee accurate test results.
Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.
Icotec Ag is recalling six VADER Pedicle System Torque Wrench devices due to a calibration error where the torque limiting function was found to be out of specification, delivering 4 Nm instead of the specified 12 Nm.
Natus Medical is recalling 249 Cranial Access Kits distributed nationwide. The sterile surgical drape liners are difficult to remove without damage, potentially rendering the kits unusable for neurosurgical procedures.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide are being recalled due to short battery run-times. All lot and serial numbers are affected.
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.
Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.
ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.
DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.
ConMed's electrosurgical suction coagulator devices may have blocked suction ports that prevent proper function during procedures. Affected devices could cause procedure delays and require alternative equipment.
Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.
3M is recalling Steri-Drape Small Towel Drapes because the adhesive liner is difficult to remove without damaging the product and has caused reported skin injuries.
Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.
DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.
Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.
ConvaTec is recalling 5,284 units of Esteem+ Durahesive Plus ostomy pouches due to impaired release liner functionality. The defect may affect proper device operation for patients managing colostomy or ileostomy output.
Stryker INBONE Tibial Trays are being recalled due to an oversized lock detail that could affect proper component assembly and implant function. Affected units were distributed in New York.
ConvaTec is recalling 3,209 units of its Active Life One-Piece Drainable Pouch due to impaired functionality of the release liner. Contact the manufacturer with your batch number.