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.

126–150 of 162

ModerateFDA (Devices)·Z-1557-2023·2023-05-10
VITROS 5600 Integrated System MicroTip Pack Opener Assembly Defect
Refurbished VITROS 5600 diagnostic systems may have a defective MicroTip Pack Opener Assembly that fails to properly remove or replace pack caps, potentially causing delayed test results. Ortho-Clinical Diagnostics is recalling 1,148 units distributed nationwide and internationally.
Product
VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1382-2023·2023-04-19
Philips DigitalDiagnost C50 Radiographic System Ceiling Suspension Malfunction Risk
The Philips DigitalDiagnost C50 radiographic system's ceiling suspension may descend unintentionally if annual maintenance is skipped and power is interrupted, potentially injuring patients and operators.
Product
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2023·2023-04-12
Abbott Alinity m System Recall: Missing Components and Improper Calibration
Abbott Molecular recalled one Alinity m System diagnostic unit installed without required plunger assemblies and returned to service without proper calibration. This could result in delayed or incorrect test results.
Product
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1293-2023·2023-04-05
Surgical Robot Instrument Carriage Loose Due to Manufacturing Defect
Intuitive Surgical is recalling da Vinci Xi and da Vinci X surgical systems because the instrument carriage can become loose due to a manufacturing defect in the linear rail component.
Product
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1140-2023·2023-03-08
Life2000 Hospital Ventilator Recalled for Potential Patient Desaturation Risk
Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.
Product
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1025-2023·2023-02-08
Cardiopulmonary Bypass Oxygenator Recalled for Loose Temperature Monitoring Adapter
Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.
Product
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2023·2023-01-18
Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent serious patient injury.
Product
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0350-2023·2022-12-07
Medical diagnostic control kit recalled for out-of-range quality control results
Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.
Product
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0280-2023·2022-11-30
Visionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage
Visionsense is recalling 205 units of its VS3 Iridium microscope because optical fiber cables may become damaged during handling, causing loss of function and outer cable heating or melting.
Product
VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0173-2023·2022-11-09
BD Multitest 6-Color TBNK tubes recalled for partial label detachment
BD Multitest 6-Color TBNK tubes are being recalled due to partial label detachment. The defect can cause tubes to stick together or lead to automation errors when used with the flow cytometer's automated loader.
Product
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute counts of human lymphocyte subsets in peripheral whole blood for immunophenotyping.
Category
Medical Device
Distribution
43 states
HighFDA (Devices)·Z-1848-2022·2022-10-05
Leica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue
Leica Microsystems is recalling 30 ARveo 8 surgical microscopes (Part Number 10449063) distributed nationwide due to a photodiode component change causing inaccurate illumination adjustment when using the BrightCare Plus Luxmeter feature.
Product
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1645-2022·2022-09-07
X-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall
Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.
Product
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1484-2022·2022-08-10
E-100 Generator electrosurgical units recalled due to preventative maintenance oversight
Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.
Product
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1395-2022·2022-08-03
CereLink ICP Monitor recalled for out-of-range pressure readings
Integra LifeSciences is recalling CereLink ICP Monitors due to electrical interference causing intracranial pressure readings to drift out of range. Affected devices may display an error message indicating sensor or extension cable failure.
Product
CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2022·2022-07-27
Hill-Rom Centrella Pro+ mattress reduced heat-moisture management performance
Affected Hill-Rom Centrella Pro+ 36-inch mattresses may have reduced Microclimate Management performance, increasing risk of pressure ulcer development. The failure affects heat and moisture control.
Product
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2022·2022-07-13
Fluoroscopic X-Ray System Stand Movement May Be Blocked During Use
Siemens Artis and Artis Q.zeego fluoroscopic X-ray systems may lose stand mobility if the robotic control system's BIOS battery discharges at startup. Field service is required to restore function.
Product
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1342-2022·2022-07-13
Siemens X-ray System Fan Wear May Cause Equipment Malfunction
Siemens is recalling 88 Artis Icono X-ray systems in the U.S. due to increased fan wear that could lead to electrical failure and malfunction of the imaging system during operation.
Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0986-2022·2022-04-27
Diagnostic imaging system software malfunction may interrupt clinical procedures
Siemens is recalling 35 Artis icono floor diagnostic imaging systems due to five potential software errors affecting equipment movements and detector control. The defects may limit functionality during procedures and could delay clinical treatment until the system is restarted.
Product
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0977-2022·2022-04-27
Artis Q zeego X-ray system recalled for inadequate cooling risk
Siemens is recalling 38 Artis Q zeego X-ray systems nationwide due to a cooling circuit malfunction that may prevent adequate cooling of the X-ray tube, triggering automatic system shutdown.
Product
Artis Q zeego, Model Number 10848283
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0980-2022·2022-04-27
Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall
Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.
Product
Artis Q.zen biplane, Model Number 10848355
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0799-2022·2022-03-23
Lumbar Puncture Trays Recalled for Manometer Leaking and Assembly Defects
Bard Peripheral Vascular Inc. is recalling 2,880 Lumbar Puncture Drug Free Trays due to defects in the manometer component involving leaking and mating issues that could affect device function.
Product
LUMBAR PUNCTURE DRUG FREE TRAY 22G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0612-2022·2022-02-16
GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect
GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.
Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0615-2022·2022-02-16
GE Healthcare MRI Superconducting Magnet Cryogen Ventilation System Defect
GE Healthcare MR superconducting magnets in SIGNA MRI systems may have cryogen ventilation systems that do not meet safety venting requirements. Approximately 17,228 systems are affected.
Product
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0476-2022·2022-01-19
Philips wireless footswitches for Allura Xper and Azurion X-ray systems recalled for connection issues
Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.
Product
Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 72
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0462-2022·2022-01-12
Alinity m System recalled for software defect in amplification detection
Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.
Product
Alinity m System, Part No. 08N53-002
Category
Medical Device
Distribution
0 states