Hazard

Device Failure recalls

240 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device failure 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.

126–150 of 240

ModerateFDA (Devices)·Z-1192-2024·2024-03-06
Dental Prosthetic Material Recall for Machining Defects
GRAPHENANO Dental G-CAM denture manufacturing material is being recalled due to machining errors that render the product unusable. The recall affects 354 units distributed in Utah.
Product
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0942-2024·2024-02-07
EZDilate Wire Guided Balloon Recalled for Device Malfunction and Patient Injury Risk
Olympus recalled 3,767 EZDilate Wire Guided Balloons due to reported inflation, deflation, and retrieval problems causing bursting, leaking, and foreign body lodgement in patients. The devices dilate strictures in the alimentary tract.
Product
EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1555
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2024·2024-02-07
EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures
Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.
Product
EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0832-2024·2024-02-07
Ophthalmic procedural kits recalled due to inadequate sterilization validation
American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.
Product
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0788-2024·2024-01-31
Power Knee Prosthetic Batteries Recalled Due to Unexpected Shutdown Risk
Ossur Power Knee prosthetic knee batteries may fail to turn on or shut down unexpectedly, potentially causing users to lose support and fall. Affected units are distributed nationwide.
Product
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2024·2023-12-27
Exactech Novation Hip System Recalled for Vacuum Seal Loss
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Product
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0504-2024·2023-12-13
Medical Catheter Sets Recalled Due to Bonding Material Defect
CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.
Product
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0353-2024·2023-11-29
BioFire FilmArray TORCH power switch may fail from electrical arcing
BioFire FilmArray TORCH diagnostic devices have a power switch that may degrade from internal arcing and carbon buildup, potentially causing electrical short, device overheating, or failure to power on.
Product
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or ap
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0179-2024·2023-11-01
Robotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect
American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.
Product
Robotics Pack, REF SSRO22D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0074-2024·2023-10-18
Flower Orthopedics Cannulated Reamer Recalled for Breaking During Surgical Use
The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.
Product
Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appropriate depth for nail insertion; Flex-Thread TM 3.2mm is provided sterile, single use. Catalogue Number: 8528-1-S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2023·2023-09-27
Stryker ACM Cement Mixing System nozzle may break during surgery
Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.
Product
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2616-2023·2023-09-27
PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect
Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.
Product
PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2465-2023·2023-09-06
LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect
Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.
Product
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TAND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2427-2023·2023-08-23
Endoscopic surgical clamp recalled for potential rotation knob failure
Carefusion recalls Snowden-Pencer MIS Diamond-Touch Clamps (Lot B23) due to potential cracking of the rotation knob from incorrect adhesive use. The 7 affected units were distributed to the US and Canada.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 45CM, RATCHETED, REF SP90-7243; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2415-2023·2023-08-23
Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2424-2023·2023-08-23
Endoscopic surgical grasper recalled due to rotation knob defect
Carefusion is recalling specific lots of Snowden-Pencer Diamond-Touch endoscopic graspers due to a manufacturing defect that may cause the rotation knob to crack or break. Affected units were distributed in the US and Canada.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2281-2023·2023-08-09
Impella RP Flex cardiac pump recalled for thrombus formation risk
The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.
Product
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2223-2023·2023-08-02
LINEAR intra-aortic balloon catheter introducer dilator fracture risk
Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.
Product
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2141-2023·2023-08-02
Hamilton C2 Ventilator recalled for software anomaly causing loss of function
FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.
Product
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2018-2023·2023-07-19
Oxylog 3000 Plus ventilator may stop working during operation
The Draeger Oxylog 3000 Plus emergency and transport ventilator may stop working when transitioning from battery to AC operation. Approximately 300 units distributed nationwide and internationally are affected.
Product
Oxylog 3000 Plus emergency and transport ventilator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2023·2023-07-19
Surgical chest support device recalled for potential cracking at attachment
Baxter Healthcare recalls 1,010 Allen Advance Chest Support devices due to potential cracking where the support attaches to operating room table rails. No injuries reported.
Product
Allen Advance Chest Support with Pad
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1829-2023·2023-07-05
Slick Set Endotracheal Tubes recalled for connector disconnection risk
Teleflex is recalling Slick Set Cuffed Endotracheal Tubes nationwide due to reported disconnection of the 15mm connector from the tube, affecting airway management in critical care settings.
Product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2008-2023·2023-07-05
ILLUMISITE Platform Console Incorrectly Converted with Non-Supplied Power Components
A Medtronic ILLUMISITE Platform Console was modified from 220-240VAC to 120VAC using non-supplied power cord and fuses, creating electrical hazards. One unit was distributed to Taiwan.
Product
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2049-2023·2023-07-05
LINK Endo-Model Knee Prosthesis Segments Recalled for Out-of-Specification Defects
The FDA has recalled 13 LINK Endo-Model knee prosthesis femoral segments because they may not meet manufacturing specifications. The defects were discovered through customer complaints.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-1778-2023·2023-06-28
Implantable Defibrillators May Deliver Reduced Energy During Therapy
Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected in the US and worldwide.
Product
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide