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.

1–25 of 162

HighFDA (Devices)·Z-2259-2026·2026-06-03
Philips Allura Imaging Systems Hard Drive Degradation Affects Functionality
Philips Allura fluoroscopic imaging systems may experience hard drive degradation after six years of service, potentially resulting in loss of imaging capability and motorized movement.
Product
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2227-2026·2026-05-27
Azurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
The deaeration hose in Philips Azurion X-ray tube cooling units may degrade over time and leak oil, affecting cooling performance and automatically triggering low-dose fluoroscopy mode.
Product
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2167-2026·2026-05-20
Hologic Selenia Dimensions Mammography Systems Loose Internal Bolts
Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.
Product
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-0
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1973-2026·2026-05-13
Halyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk
AVID Medical is recalling the Halyard CATH LAB kit (Model SACL75AM) because the syringe rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard CATH LAB kit. Model Number: SACL75AM.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1972-2026·2026-05-13
Halyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
AVID Medical is recalling Halyard CARDIAC CATH TRAY SHANDS JAX kits due to a defect in the Medline syringe rotating adaptor that may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-1998-2026·2026-05-06
Heraeus PALAMIX duo dental mixing system batches worldwide recall
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.
Product
Heraeus, PALAMIX duo. Material Number: 66057897.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1913-2026·2026-04-29
Arrow Epidural Catheter Kits Recalled Due to Adhesive Manufacturing Defect
Arrow International is recalling FlexTip Plus Epidural Catheter and FlexBlock Continuous Peripheral Nerve Block Catheter Kits due to incorrect manufacturing of liquid adhesive. The recall affects 190 units distributed nationwide.
Product
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-05502-BSM UDI code: (01)10801902209853(17)270831(11)251210(10)33F25K0409 The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural ane
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1904-2026·2026-04-29
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2116) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1900-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1902-2026·2026-04-29
OER-ELITE Endoscope Reprocessor Connecting Tubes Lock Lever Failure Risk
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1663-2026·2026-04-08
X-ray imaging system intermittent operation due to foot switch malfunction
Philips ALLURA Xper FD20 X-ray systems may fail to initiate imaging or operate intermittently when using the wired foot switch. Affected medical facilities should contact Philips for service evaluation.
Product
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1534-2026·2026-03-18
GEM Premier 5000 cartridges recalled for startup errors
Instrumentation Laboratory is recalling GEM PAK cartridges for the GEM Premier 5000 analyzer due to startup errors that may delay test results. The recall affects 195 units with 19 affected lot numbers.
Product
GEM Premier 5000; Part No. 00055415008.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1494-2026·2026-03-11
Olympus ShockPulse-SE Lithotripsy System Generator Mis-wired Component Recall
Olympus ShockPulse-SE lithotripsy system generators have a mis-wired component causing electrical noise that violates electromagnetic compatibility standards. This may reduce system reliability and delay kidney stone treatment. 55 units affected in Canada, Germany, Singapore, Australia, and India.
Product
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1350-2026·2026-02-18
Azurion 5 M12 Imaging System Table May Move Unexpectedly During Operation
Philips Azurion 5 M12 imaging system tables may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is active, posing a safety risk during medical procedures.
Product
Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2026·2026-02-18
Medical imaging system recalled for unexpected table movement
Philips Azurion 7 B20 fluoroscopy systems may move unexpectedly when the Reset Geometry button is pressed, even with the table lock engaged, creating a potential safety risk during medical procedures.
Product
Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1227-2026·2026-02-11
Dialyzer Deaeration Chamber Potential Dislodgement Prompts Safety Recall
VANTIVE's PRIMSAFLEX M100 dialyzer sets may have a deaeration chamber that could dislodge from the control unit. Approximately 230,596 units distributed nationwide are affected.
Product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1190-2026·2026-02-04
Medline procedure convenience kits recalled for cracking tubing defect
Medline medical procedure kits are being recalled due to complaints that butyrate tubing cracks during actuation of MASTISOL Liquid Adhesive vials. The kits are distributed nationwide.
Product
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, K
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1177-2026·2026-02-04
Fluoroscopic x-ray system ceiling suspension screws may become loose
Canon Medical's Alphenix interventional x-ray systems may have loose fixing screws in the ceiling movement gear, potentially preventing lateral movement and causing sensor errors. 98 units worldwide are affected.
Product
Alphenix INFX-8000F, interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2026·2026-02-04
Medline surgical procedure kits recalled for defective adhesive vial tubing
Medline is recalling 1,928 medical procedure convenience kits due to defective tubing in MASTISOL liquid adhesive vials that may crack during use. The kits were distributed nationwide to healthcare facilities.
Product
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0415776Q; 3) DIVA PACK, Kit SKU DYNJ04811O; 4) DA VINCI PROSTATE/COLPOPEXY, Kit SKU DYNJ44864S; 5) MH ROBOTICS PACK, Kit SKU D
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1179-2026·2026-02-04
Alphenix Interventional X-Ray Systems Ceiling Movement Gear Fasteners May Loosen
Canon Medical's Alphenix INFX-8000V x-ray systems may have loose ceiling movement gear screws, risking loss of ceiling lateral movement, abnormal noise, and sensor errors across 332 units worldwide.
Product
Alphenix INFX-8000V, interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1178-2026·2026-02-04
Alphenix X-ray System Ceiling Screws May Loosen, Affecting Equipment Movement
Canon Medical is recalling three Alphenix INFX-8000H interventional x-ray systems. Ceiling-mounted fixing screws may loosen, potentially preventing equipment movement, generating abnormal noise, or triggering sensor errors. No injuries have been reported.
Product
Alphenix INFX-8000H, interventional fluoroscopic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2026·2026-01-21
Medicrea Orthopedic Rotation Tool Handle May Detach During Surgery
Medicrea is recalling IB3D PL Instruments Sets because the orthopedic rotation tool handle may detach from the shaft, preventing implant rotation during surgery. The Class II recall affects 44 units distributed across nine U.S. states.
Product
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1070-2026·2026-01-21
Philips X-ray system cooling drip tray missing in limited units
In limited Allura Xper FD20 X-ray systems, the cooling unit drip tray was not installed or inadequately documented. This creates a potential for coolant to contact electrical components and trigger system shutdown.
Product
Allura Xper FD20; Model Number: 722012;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2026·2025-12-03
Philips Azurion Medical Imaging System Motorized Movement May Become Unavailable
Philips Azurion 7M20 X-ray imaging systems may experience inconsistent or unavailable motorized movement on the ceiling-mounted FlexArm arm due to bearing lubrication failure affecting 172 units.
Product
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-0515-2026·2025-11-26
Medline Breast Biopsy Kits Recalled for Smoke Evacuation Pencil Malfunction
Medline is recalling breast biopsy kits with SafeAir Smoke Evacuation Pencils that may activate without manual input when plugged in or remain active when buttons are released. The recall affects 301 units distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
Category
Medical Device
Distribution
Distributed nationwide