Hazard
450 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (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 device 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.
Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.
Microvention Inc. is recalling 5,500 Bobby Balloon Guide Catheters worldwide due to an increased rate of balloon pinhole defects.
Medtronic Perfusion Systems is recalling EOPA Elongated One-Piece Arterial Cannula Model 77722 due to potential pinhole leaks in the wire-wound body during use.
Abiomed, Inc. is recalling ABIOMED Impella CP Introducer Kit 14 Fr units worldwide due to potential introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable.
Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.
Medline Industries is recalling multiple cardiac catheterization kits due to the presence of particulate matter in the fluid path of manifolds. The affected kits were distributed nationwide and internationally.
Medline Industries is recalling multiple cardiac catheterization kits because particulate contamination has been found within the fluid path of the manifolds used in these kits.
Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.
Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps (Model DVF4034-27) distributed worldwide. The specific hazard or reason for the recall is not stated in the available source information.
Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.
Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Angiodynamics recalls AccuVu Angiographic Catheters due to a manufacturing defect that may prevent guidewires from passing through the catheter hub. The affected devices were distributed worldwide.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
HeartSine Technologies is recalling 1,291,165 Pad-Pak units because defibrillator pads may contain damaged pins that disrupt the mechanical fit and electrical contact.
Abbott is recalling 3,404 TactiFlex Sensor Enabled Ablation Catheters in the D-D curve after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 1,960 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve F configuration after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 407 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve D configuration after becoming aware of tip detachment events during removal from the packaging.
Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.
Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Baxter is recalling 49,200 Continu-Flo solution sets with a 4-way stopcock extension set because the IV sets may leak.
Baxter is recalling 48,096 CLEARLINK System non-DEHP Continu-Flo solution sets from one lot because the IV sets may leak.
Baxter is recalling 69,936 CLEARLINK System non-DEHP extension sets with a 1.2 micron filter across two lots because the IV sets may leak.