Hazard

Device Malfunction recalls

877 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 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.

26–50 of 877

HighFDA (Devices)·Z-1862-2026·2026-04-29
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided manufacturing defect
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1939-2026·2026-04-29
Diversatek Healthcare Viper Balloon Dilator catheter inflation tag error
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the catheter inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1859-2026·2026-04-29
Soft-Vu Angiographic Catheter Recalled for Guidewire Passage Defect
Angiodynamics recalls Soft-Vu Angiographic Catheters with a manufacturing defect preventing proper guidewire passage through the catheter hub. The affected devices may not function as intended. No injuries have been reported.
Product
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1871-2026·2026-04-29
Angiodynamics Soft-Vu Angiographic Catheter Kumpe Recall
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe devices due to a manufacturing defect that may prevent guidewire passage through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1864-2026·2026-04-29
Soft-Vu Angiographic Catheter Cobra Non-Braided Manufacturing Defect
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2026·2026-04-29
AccuVu Angiographic Catheter recalled for guidewire passage defect
Angiodynamics is recalling the AccuVu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a properly sized guidewire from passing through the catheter hub's inner diameter.
Product
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1872-2026·2026-04-29
AccuVu Angiographic Catheter recall due to manufacturing defect
Angiodynamics is recalling AccuVu Angiographic Catheters due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub. The defect could interfere with proper device function during medical procedures.
Product
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2026·2026-04-29
Olympus Thunderbeat II surgical shears recalled for potential distal tip detachment
Olympus is recalling Thunderbeat II 5mm ultrasonic surgical shears (model TB2-0535FC) due to potential detachment of the distal tip component during use. Approximately 3,360 units have been distributed internationally.
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1873-2026·2026-04-29
AccuVu Angiographic Catheter Manufacturing Defect Recall Worldwide
Angiodynamics is recalling AccuVu Angiographic Catheters worldwide due to a manufacturing defect that may prevent guidewires from passing through the catheter hub's inner diameter.
Product
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H787137096040 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1918-2026·2026-04-29
Rover Mobile X-ray System may malfunction and become inoperable
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1909-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Levers Failure Risk
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1910-2026·2026-04-29
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 Medical Device Recall
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
Product
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1908-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2138) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers. The defect could affect proper tube attachment during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1901-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2113) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The defect could affect proper connection during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1828-2026·2026-04-29
CUSA Clarity C7000 Ultrasonic Surgical Aspirator Touch Screen Unresponsiveness
Integra LifeSciences is recalling the CUSA Clarity C7000 Console (Software Version 2.1.1.909) due to a software issue that renders the touch screen unresponsive during surgical use.
Product
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1865-2026·2026-04-29
Soft-Vu Angiographic Catheter Cobra Non-Braided recalled by Angiodynamics
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Product
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1812-2026·2026-04-22
Endoscopic Clipping Device Recall Due to Malfunction Risk
Wilson-Cook Medical is recalling the Instinct Plus Endoscopic Clipping Device due to increased complaints indicating potential device malfunction. Approximately 713,702 units were distributed nationwide and internationally.
Product
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1728-2026·2026-04-15
Medline medical convenience kits with defective syringe rotating adaptors recalled
Medline is recalling 439 medical convenience kits worldwide containing defective NAMIC Angiographic RA Control Syringes. The syringe rotating adaptor may unwind during use, causing loose or full disconnection between the syringe and manifold.
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1649-2026·2026-04-08
Philips Respironics Trilogy Evo Universal Ventilator Obstruction Alarm Delay Recalled
Philips Respironics Trilogy Evo Universal ventilator software version 1.05.15.00 recalled because the obstruction alarm may fail to trigger within required timeframes, potentially delaying critical responses to airway obstruction.
Product
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2026·2026-04-08
Philips Allura Xper OR Table May Fail to Initiate X-Ray Imaging
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently on the Allura Xper FD20/15 OR Table when using the wired foot switch. This malfunction could impact imaging-guided surgical procedures.
Product
Allura Xper FD20/15 OR Table; System Code: 722059;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1670-2026·2026-04-08
Philips Allura Xper FD20/20 operating room X-ray table foot switch imaging defect
Philips has recalled the Allura Xper FD20/20 operating room X-ray table due to wired foot switch defects that may prevent or intermittently delay X-ray imaging. Five affected units have been distributed internationally.
Product
Allura Xper FD20/20 OR Table; System Code: 722039;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1704-2026·2026-04-08
Finesse BTK Multicath Balloon Catheter Recalled for Burst Specification Risk
SUMMA THERAPEUTICS recalled the Finesse BTK Multicath balloon catheter due to the potential that the balloon may not meet burst specifications. The recall affects 22 units in New Jersey and Florida.
Product
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon le
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2026·2026-04-08
Philips Azurion 7 B12 X-ray system wired foot switch malfunction recall
Philips is recalling Azurion 7 B12 X-ray imaging systems due to a wired foot switch defect that may prevent or cause intermittent X-ray image initiation.
Product
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1659-2026·2026-04-08
Philips Allura Xper FD10C X-ray System Foot Switch Malfunction
Philips is recalling Allura Xper FD10C X-ray imaging systems due to a wired foot switch malfunction that may prevent or intermittently interrupt imaging. The recall affects 15 units distributed across the U.S. and internationally.
Product
Allura Xper FD10C; System Code: 722001;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1687-2026·2026-04-08
Artoura Breast Tissue Expanders recalled for defective needle tips
Mentor Texas is recalling Artoura Breast Tissue Expanders because their infusion sets contain dull or blunt needle tips that may be difficult to advance and may break during use.
Product
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Category
Medical Device
Distribution
Distributed nationwide