Hazard

Equipment Malfunction recalls

162 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 equipment 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.

101–125 of 162

HighFDA (Devices)·Z-1598-2024·2024-04-24
Siemens Artis X-ray systems cooling malfunction may halt procedures
Siemens Artis interventional X-ray systems may fail to cool the X-ray tube adequately, causing system shutdown and potentially requiring cancellation of clinical imaging procedures. The recall affects 583 units distributed nationwide.
Product
Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 10094137 Artis zee multi-purpose- 10094139 Artis zee biplane- 10094141 Artis zeego- 10280959 Artis Q floor- 10848280 Artis Q ceiling- 10848281 Artis Q bipl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1538-2024·2024-04-24
Masimo Rad-G Pulse Oximeter automatic power cycling may cause monitoring loss
Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.
Product
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2024·2024-03-13
VITROS XT7600 System Aspiration Risk During Sample Processing
Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.
Product
VITROS XT7600 Integrated System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1214-2024·2024-03-06
Colonoscope Model PCF-Q180AL Recalled Due to Missing Protective Adhesive
Olympus Corporation of the Americas is recalling Colonoscope Model PCF-Q180AL units that were assembled without protective adhesive. This missing adhesive protects the device from vibration, temperature fluctuations, and physical shock during use.
Product
Colonoscope, Model Number PCF-Q180AL.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1207-2024·2024-03-06
Colonoscope Model CF-HQ190L Recalled Due to Missing Protective Adhesive
Olympus Corporation is recalling 97 Colonoscope Model CF-HQ190L units distributed nationwide. The devices were assembled without protective adhesive, risking malfunction under vibration, temperature changes, or shock.
Product
Colonoscope, Model Number CF-HQ190L.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2024·2024-02-28
X-ray fluoroscopy system may display abnormal images due to detector board defect
Canon Medical's INFX-8000F X-ray system may display abnormal horizontal stripe patterns due to a manufacturing change in the flat panel detector's internal board, potentially preventing exam completion.
Product
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0975-2024·2024-02-14
Patient transportation system wheels may be attracted to MRI magnetic fields
Ingenia Ambition X patient transportation system trolleys contain magnetic wheels that may be attracted to MRI magnetic fields, potentially causing trolley malfunction during patient procedures.
Product
Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0281-2024·2024-02-07
Vancomycin IV bags recalled due to filling system malfunction causing double doses
Denver Solutions is recalling 10,152 Vancomycin IV bags nationwide because a filling system malfunction can deliver double doses of the antibiotic medication.
Product
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0278-2024·2024-02-07
FentaNYL Citrate IV Bags Recalled Due to Double-Dose Filling System Malfunction
FentaNYL citrate intravenous bags are recalled nationwide because a semi-automated filling system can malfunction and deliver double the intended dose. Patients and healthcare providers should immediately quarantine affected lots.
Product
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2024·2024-01-24
Suction Canister Liner Recalled for Loss of Suction on Low Settings
Cardinal Health Suction Canister Liners may lose suction on low or intermittent settings due to liner misalignment. Approximately 3.5 million units are affected across the US, Canada, Australia, and New Zealand.
Product
CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0589-2024·2023-12-27
Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2024·2023-12-27
Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0437-2024·2023-12-13
DRX Revolution Mobile X-Ray System Electrical Component Failure Recall
Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.
Product
DRX Revolution Mobile X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0406-2024·2023-12-06
Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery
Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.
Product
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0417-2024·2023-12-06
Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk
Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.
Product
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0324-2024·2023-11-29
Solea Laser Surgical Instrument Models 2.0 and 3.0 Recall for Unintended Activation
Convergent Dental is recalling 39 Solea laser surgical instruments due to potential unintended laser activation without foot pedal depression. No injuries have been reported.
Product
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2024·2023-11-29
Manual resuscitators recalled due to carbon dioxide rebreathing defect
SunMed Holdings recalls Ventlab STAT-Check manual resuscitators due to a backwards leak in the integrated manometer allowing CO2 rebreathing, which may impair ventilation. Multiple models (Adult, Infant, Pediatric) are affected and distributed nationwide.
Product
Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2540-2023·2023-09-20
Landauer nanoDot radiation dosimeters recalled for measurement accuracy defect
Landauer recalled 5,760 nanoDot D2DNN radiation dosimeter units worldwide due to potential inaccuracy in radiation measurement. Some units may read outside the specified +/-5.5% accuracy range due to a defect in the optical stimulated luminescence material.
Product
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2404-2023·2023-09-13
Medical Imaging System Recalled for Foot Pedal Malfunction Risk
Philips MultiDiagnost-Eleva imaging systems may emit unintended radiation if the foot pedal gets stuck in the active position. The FDA is alerting healthcare facilities to this potential equipment malfunction.
Product
MultiDiagnost-Eleva
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2392-2023·2023-08-16
Canon Medical INFX-8000C Tableside Console PWB Requires Replacement
Canon Medical has recalled 12 INFX-8000C tableside consoles due to a printed circuit board that may require replacement. Though procedures may be delayed, x-ray operations can continue using alternative controls.
Product
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2023·2023-08-02
Hernia repair mesh balloon may not inflate during surgery
Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.
Product
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2053-2023·2023-07-12
TrackMaster TMX428 Treadmill drive circuit board malfunction recall
Drive board malfunction in TrackMaster TMX428 treadmills can cause unexpected belt reversal or acceleration, creating fall and impact injury risks. 376 units affected.
Product
TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1647-2023·2023-06-07
Philips Azurion X-ray Systems May Lose Imaging Capability When Storage Full
Philips Azurion X-ray imaging systems may suddenly lose X-ray functionality when disk storage capacity is reached, potentially interrupting medical procedures.
Product
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1449-2023·2023-05-24
VentStar Watertrap breathing circuit connections may detach during ventilation
Draeger Medical is recalling the VentStar Watertrap (N) 180 due to glued breathing circuit connections that may become loose or detach during ventilation, posing patient safety risk.
Product
VentStar Watertrap (N) 180, MP00363
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1477-2023·2023-05-10
Philips ProxiDiagnost N90 radiography systems recalled due to cable damage
Philips is recalling certain ProxiDiagnost N90 radiography systems due to a cable under the table that may break. A broken cable could prevent users from tilting the table or engaging braking.
Product
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) system
Category
Medical Device
Distribution
Distributed nationwide