Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

876–900 of 13399

ModerateFDA (Devices)·Z-1384-2026·2026-02-25
Medline convenience kits recalled for sterilization equipment calibration issues
Medline Industries recalls 551 sterilization and anesthesia convenience kits due to calibration defects in manufacturing equipment that may compromise product sterility assurance.
Product
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1324-2026·2026-02-18
Reprocessed Diagnostic Ultrasound Catheters Recalled for Residual Particles
Reprocessed Biosense Webster SOUNDSTAR eco diagnostic ultrasound catheters may contain residual particles that could cause blood clots or infection. Medline Industries is recalling 94 units distributed nationwide.
Product
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Bios
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1323-2026·2026-02-18
Medline Reprocessed ICE Catheters Recalled for Residual Material
Medline Industries is recalling 650 units of ReNewal Reprocessed ViewFlex Xtra ICE Catheters due to contamination with residual material particles. These defective devices pose a risk of serious infection and life-threatening blood clots.
Product
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1325-2026·2026-02-18
Reprocessed Siemens ACUSON AcuNav Ultrasound Catheters Recalled for Particle Contamination
Medline Industries is recalling 511 reprocessed Siemens ACUSON AcuNav ultrasound catheters due to residual material particles. These particles may cause systemic infection, blood clots, or embolism.
Product
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1321-2026·2026-02-18
Reprocessed Livewire Electrophysiology Catheters Recalled for Contamination Risk
Medline Industries is recalling reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters nationwide due to potential contamination with residual material particles that may cause serious infections or blood clots.
Product
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Cath
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1322-2026·2026-02-18
Reprocessed electrophysiology catheters recalled for residual material contamination
Medline Industries is recalling 48 units of reprocessed St. Jude diagnostic electrophysiology catheters due to residual material that may cause systemic infection, blood clots, or embolism.
Product
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 40143
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1319-2026·2026-02-18
Medline Reprocessed Cardiac Catheters Recalled for Particle Contamination Risk
Medline reprocessed cardiac catheters may contain residual material particles, risking systemic infection, blood clots, and embolism. Affected units should be immediately quarantined and returned.
Product
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm S
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1320-2026·2026-02-18
Reprocessed diagnostic catheters recalled for residual material contamination
Medline Industries recalls reprocessed Abbott diagnostic catheters that may contain particles of residual material. Use could cause infection, inflammatory response, blood clots, or embolism.
Product
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2026·2026-02-18
Halyard Transport Bag Kit Recalled for Potential Sterility Compromise
AVID Medical is recalling Halyard Transport Bag Kits (Kit Code LIFE0080-01) due to a Tyvek bag seal defect that may compromise the sterility of the kit. No illnesses or injuries have been reported.
Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2026·2026-02-18
Alphatec ATEC Lateral Navigation Disc Prep Instruments recalled for design defect
Alphatec Spine, Inc. is recalling ATEC Lateral Navigation Disc Prep Instruments due to a design issue affecting the navigated array connection geometry. These surgical instruments may not function properly during spine surgery procedures.
Product
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1326-2026·2026-02-18
Medline Anesthesia Artline Packs Recalled for Potential Packaging Defects
Medline Industries is recalling 120 Anesthesia Artline medical convenience kits due to BD ChloraPrep Triple Swabsticks with potentially open seals. Open packaging could compromise product sterility.
Product
Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1361-2026·2026-02-18
Medical device recall: Barco MNA adapter configuration manufacturing defect
Steris Corporation is recalling 10 Barco MNA medical devices with HexaVue IP Integration System (Model MNA-6x0-H) due to an incorrect configuration file used during manufacturing of adapter components. Affected devices were distributed across seven U.S. states.
Product
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2026·2026-02-18
Leksell GammaPlan treatment planning software may target incorrect patient location
Leksell GammaPlan version 11.1 software contains an error in stereotactic reference definition that may result in radiation treatment being planned for an incorrect patient location.
Product
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2026·2026-02-18
ATEC Lateral Navigation Disc Prep Instruments recalled for connection geometry defect
Alphatec Spine is recalling ATEC Lateral Navigation Disc Prep Instruments due to incorrect connection geometry in the navigated array. Seven units in Lot EM49968 are affected across multiple U.S. states.
Product
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1314-2026·2026-02-18
Hologic Brevera Breast Biopsy Needle Recall: Particulate Contamination Risk
Hologic is recalling over 681,000 Brevera Breast Biopsy System disposable 9 gauge needles due to potential particulate contamination that may deposit into breast tissue during use.
Product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2026·2026-02-18
Medline Medical Kits Recalled Due to Potentially Open Applicator Packaging
Medline Industries is recalling 21,854 units of sterile medical device kits containing ChloraPrep Triple Swabsticks due to potential open seals on applicator packaging. No illnesses have been reported.
Product
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT, Kit SKU DT22790C; 4) PROCEDURE TRAY, Kit SKU DYNDA2966A; 5) PROCEDURE TRAY, Kit SKU DYNDA2966A; 6) PEDIATRIC CENTRAL LINE SMALL, Kit SKU DYNDC2208C; 7) PORT DRESSING KIT, Kit S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2026·2026-02-18
Medline Medical Convenience Kits Recalled for Unsealed Applicators
Medline Industries recalls 7,380 medical convenience kits nationwide due to potentially open seals on BD ChloraPrep Triple Swabstick applicators, which could affect product sterility.
Product
Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1348-2026·2026-02-18
Philips Azurion 7 M12 Imaging System Table Unexpected Movement Risk
Philips has recalled the Azurion 7 M12 imaging system because the examination table may move unexpectedly when the Reset Geometry button is pressed, even if the table lock is active. This could pose a patient safety risk.
Product
Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2026·2026-02-18
Philips Azurion 7 M20 System table moves unexpectedly despite active lock
Philips is recalling the Azurion 7 M20 imaging system because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is engaged. Approximately 5,136 units are affected worldwide.
Product
Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1346-2026·2026-02-18
Philips Azurion 7 B12 Medical System: Unexpected Table Movement Risk
The Philips Azurion 7 B12 medical imaging system may experience unexpected table movement when the Reset Geometry button is pressed, even if the table lock is engaged. This could affect patient safety during medical procedures.
Product
Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2026·2026-02-18
Medline pediatric catheter securement kits recalled for potential open packaging seals
Medline Industries is recalling 450 pediatric catheter securement dressing kits nationwide due to potential open seals on BD ChloraPrep applicator packaging. Open seals may compromise product sterility and integrity.
Product
Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108
Category
Medical Device
Distribution
Distributed nationwide
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-1351-2026·2026-02-18
Philips Azurion 5 M20 fluoroscopy table may move unexpectedly
Philips is recalling 922 Azurion 5 M20 fluoroscopy systems because the patient table may move unexpectedly when the Reset Geometry button is pressed, even when the table lock is active.
Product
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2026·2026-02-18
Medline Medical Kits With BD ChloraPrep Swabsticks Recalled for Open Packaging Seals
Medline Industries is recalling 8,445 medical convenience kits nationwide due to open seals on BD ChloraPrep Triple Swabstick applicator packaging. The defect may compromise product sterility.
Product
Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1344-2026·2026-02-18
Medical Imaging System Table May Move Unexpectedly During Reset
Philips Azurion 3 M12 fluoroscopy systems may experience unexpected table movement when the Reset Geometry button is pressed, even when the table lock is active. The recall affects 291 units distributed worldwide.
Product
Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X
Category
Medical Device
Distribution
Distributed nationwide

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