The Recall Desk

Category

Medical device recalls

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

1176–1200 of 13399

  • HighFDA (Devices)·Z-1056-2026·2026-01-21

    Medline IV Administration Kits Recalled for Stuck Check Valve Defect

    Medline recalls IV administration kits because check valve components may become stuck, potentially affecting medication delivery. The recall affects 5,314 units distributed nationwide.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS, Medline kit SKU DYKM1980C; 2) (134) L&D IV-START SET, Medline kit SKU DYKM2137B; 3) IV START KIT, Medline kit SKU DYKS1372C; 4) IV START KIT, Medline kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1071-2026·2026-01-21

    Philips Allura Xper FD20 biplane coolant leak risk from undocumented drip tray

    Philips has identified that some Allura Xper FD20 biplane systems may have uninstalled or undocumented drip trays beneath the cooling unit, creating risk for coolant to contact electrical components and cause system shutdown.

    Product
    Allura Xper FD20 Biplane; Model Number: 722013;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2026·2026-01-21

    Medline Cardiac Procedure Kits Recalled Due to Stuck Check Valve in IV Administration Sets

    Medline has recalled 633 kits containing B. Braun IV Administration Sets and Pump Administration Sets due to customer complaints that check valve components may become stuck in open or closed positions.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2026·2026-01-21

    Medline IV Administration Kits Recalled Due to Check Valve Malfunction

    Medline is recalling IV administration kits containing B. Braun administration sets because check valve components may become stuck in open or closed positions. Ninety-six units were distributed nationwide.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2026·2026-01-21

    Philips Allura Xper FD10F Medical Imaging System Electrical Short-Circuit Risk

    Philips is recalling 12 Allura Xper FD10F angiography systems worldwide because the cooling system's drip tray may not be installed. Without the tray, coolant could contact electrical components and cause short-circuits leading to system shutdown.

    Product
    Allura Xper FD10F; Model Number: 722002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2026·2026-01-21

    Allura Xper FD10 medical imaging system recalled for cooling drip tray issue

    Philips recalls 93 Allura Xper FD10 imaging systems due to missing or undocumented drip tray installations, which could allow coolant to contact electrical components and cause system shutdown.

    Product
    Allura Xper FD10; Model Number: 722003;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2026·2026-01-21

    CT X-ray System Component Recalled for Missing Safety Label

    Mobius Imaging is recalling 101 AIRO CT X-ray system pendant components lacking the required 'Safe Hand Position Warning' label, which informs operators of proper positioning during use.

    Product
    Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1043-2026·2026-01-21

    Vanta Clinician Programmer Application versions recalled for software malfunction

    Medtronic recalls versions 2.0.2465 and 2.0.2683 of the Vanta Clinician Programmer Application. The software does not function as intended, creating potential for prolonged or postponed surgical procedures.

    Product
    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2026·2026-01-21

    Philips Azurion X-ray Systems software defect may cause imaging loss and system failures

    Philips Azurion X-ray imaging systems may experience nine software issues causing loss of X-ray imaging, system restarts, and diagnostic tool misalignment. 990 units distributed worldwide are affected.

    Product
    Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2026·2026-01-21

    Medline IV Administration Kits Recalled for Check Valve Malfunction

    Medline has recalled multiple kits containing B. Braun IV administration sets because the check valve components may become stuck in open or closed positions. The recall affects 3,045 units distributed nationwide.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2026·2026-01-21

    Measurement Spectrometer Laser Safety Defect from Cable Failure

    The MAVERICK Measurement Module Spectrometer has a cable defect that can cause elevated laser output (approximately 1,600 mW) or unintended laser firing during measurement cycles. No injuries have been reported.

    Product
    MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1051-2026·2026-01-21

    Medline IV Administration Kits recalled for stuck check valve defect

    Medline is recalling certain pre-op kits due to check valve defects in IV and pump administration sets. The valves may become stuck in either position, potentially impairing medication delivery.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2026·2026-01-21

    Arterial blood sampling kits recalled for cracked syringe collars and leakage risk

    ICU Medical is recalling certain Pulsator Arterial Blood Sampling Kits due to cracks in the syringe collar that may cause blood leakage or delayed delivery during arterial sampling.

    Product
    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2026·2026-01-21

    Philips imaging system missing cooling unit drip tray installation

    Certain Philips Allura Xper FD20/10 imaging systems may lack a required drip tray beneath the cooling unit. If missing, coolant could contact electrical components and cause system shutdown.

    Product
    Allura Xper FD20/10; Model Number: 722029;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2026·2026-01-21

    Nuclear Medicine Imaging Systems: Risk of Detector Fall During Transport

    GE HealthCare is recalling certain nuclear medicine imaging systems with potentially compromised detector mounting mechanisms that could fail during transport. No injuries have been reported, but detector falls could cause serious harm.

    Product
    SMV DSI, System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1041-2026·2026-01-21

    AIRO CT Pendant Upgrade Missing Safe Hand Position Warning Label

    Mobius Imaging is recalling 26 AIRO CT pendant upgrade components lacking a required 'Safe Hand Position Warning' label. The missing label could prevent users from recognizing safe hand positioning during equipment operation.

    Product
    Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1018-2026·2026-01-21

    MRI systems recalled for potential helium vessel rupture during emergency discharge

    Canon Medical's VANTAGE TITAN 3T MRI systems may develop ice in the magnet vent system, which could trap helium gas and cause vessel rupture if an emergency discharge occurs, releasing pressurized helium into the scanning room.

    Product
    VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2026·2026-01-21

    da Vinci SP Access Port Kit System Tray Cracks Risk Sterility Breach

    Intuitive Surgical is recalling da Vinci SP Access Port Kits because the system tray may develop cracks that could breach sterility during surgical use.

    Product
    da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1054-2026·2026-01-21

    Medline IV Administration Kits Recalled for Stuck Check Valve Components

    Medline kits containing B. Braun IV Administration Sets are recalled because check valve components may become stuck, potentially affecting medication delivery. Lot Number 25HBQ850 is affected.

    Product
    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
    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
  • HighFDA (Devices)·Z-1042-2026·2026-01-21

    Boston Scientific Coyote Balloon Dilation Catheter Inflation Deflation Failure

    Boston Scientific is recalling certain batches of Coyote Over-the-Wire Balloon Dilation Catheters that may not properly inflate or deflate during use in peripheral vessels.

    Product
    Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2026·2026-01-21

    Philips medical imaging system may lack cooling unit drip tray

    The Philips Allura Xper FD20 fluoroscopy system may lack a drip tray beneath its cooling unit, potentially allowing coolant to contact electrical components and cause device shutdown. The recall affects 143 units worldwide.

    Product
    Allura Xper FD20; Model Number: 722006;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2026·2026-01-21

    Philips Allura Xper FD10 medical imaging system drip tray installation issue

    Philips is recalling the Allura Xper FD10 because the drip tray beneath the cooling unit may not be installed in some units, potentially allowing coolant to contact electrical components and cause system shutdown.

    Product
    Allura Xper FD10; Model Number: 722026;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2026·2026-01-21

    Medline Surgical Procedure Kits Recalled Due to Irrigation Solution Leakage

    Medline is recalling 12,584 surgical procedure kits containing Stryker Strykeflow 2 irrigators due to a design defect that causes irrigation solution to leak and emit vaporized saline during use.

    Product
    Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1081-2026·2026-01-21

    PALACOS R+G pro bone cement recalled for ampoule breakage defect

    PALACOS R+G pro bone cement is recalled due to defects that prevent ampoule breakage, blocking cement dough formation and making the product unusable.

    Product
    Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl
    Category
    Medical Device
    Distribution
    0 states

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