Hazard
63 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 63 device fracture recalls we have scored against our rubric, 7 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (48%) are Severe.
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device fracture 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.
Surgify Halo 40 mm surgical burrs are being recalled because they may break during bi-portal endoscopic spinal surgery, potentially creating risks during the procedure.
Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.
Maquet Cardiovascular is recalling the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a ceramic C-Ring component that may break during use. At least 12 user complaints were reported as of March 3, 2025.
Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.
Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.
Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.
The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.
LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.
Boston Scientific is recalling Emblem S-ICD Subcutaneous Electrodes because fractures may prevent the device from delivering therapy.
Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.
Stryker Neurovascular is recalling Trevo XP ProVue Retriever devices due to increased fracture complaints of the core wire, which can cause the stent retriever to separate and remain in the patient's vasculature.
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
MicroPort Orthopedics is recalling specific PROFEMUR Titanium hip prosthesis components due to reports of fractures after implantation.
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
CTL Medical Corporation is recalling 45 units of CEZANNE II TLIF Bullet-Tip Cages because reports indicate the devices fractured during insertion.
CTL Medical Corporation is recalling 39 units of CEZANNE II TLIF Bullet-Tip Cage because reports indicate the device fractured during insertion.
Kentec Medical is recalling 70 ENFit feeding tubes because the plastic tethered closure cap may fracture, potentially delaying care or causing unnecessary radiation exposure.
Kentec Medical is recalling 2,850 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Kentec Medical is recalling 170 ENFit enteral feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Kentec Medical is recalling 480 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.
Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.
Encore Medical is recalling 86 units of EMPOWR Acetabular Impactor Balls because they may fracture during use, potentially leaving debris in the joint space.
Stryker Neurovascular is recalling 1,405 AXS Vecta 74 Aspiration Catheters because they may break, fracture, or kink if improperly removed or during use.
Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part in the patient.