The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

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1276–1300 of 13414

  • CriticalFDA (Devices)·Z-0914-2026·2025-12-24

    GE Healthcare Carestation anesthesia systems may unexpectedly shutdown on power loss

    GE Healthcare is recalling Carestation anesthesia systems that may shut down unexpectedly during power loss, potentially disrupting mechanical ventilation and volatile agent delivery. This FDA Class I recall affects 888 units distributed worldwide.

    Product
    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0913-2026·2025-12-24

    GE Healthcare Carestation anesthesia systems may unexpectedly shut down during power loss

    GE Healthcare is recalling Carestation anesthesia systems that may unexpectedly shut down if AC power is lost, potentially disrupting ventilation and anesthetic delivery during surgery.

    Product
    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0885-2026·2025-12-24

    Ivenix Infusion System Software Versions 5.10.1 and Earlier Recalled

    Fresenius Kabi is recalling Ivenix Infusion System software versions 5.10.1 and earlier due to software anomalies that could cause serious patient harm or death.

    Product
    Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0915-2026·2025-12-24

    GE Carestation anesthesia system shutdown risk during AC power loss

    GE Healthcare Carestation 600 and 700 Series anesthesia systems with certain power boards may unexpectedly shut down during AC power loss, with temporary disruption of ventilation and loss of previous settings after reboot.

    Product
    GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2026·2025-12-24

    Myosa for Kids mouthguards recalled for missing FDA premarket approval

    Myofunctional Research Company USA is recalling 436 Myosa for Kids mouthguards distributed nationwide and in Australia without FDA premarket clearance. The devices are intended for children ages 3-15 to address breathing and myofunctional disorders.

    Product
    Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to address breathing and myofunctional disorders. Catalog Numbers:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2026·2025-12-24

    Arteriogram Device Recalled Due to Potential Incomplete Header Bag Seal

    AVID Medical is recalling Halyard MIDTOWN GENERAL ARTERIOGRAM devices due to potential incomplete seals on header bags that could compromise product sterility. Approximately 300 units (Lot 1635477) were distributed to healthcare facilities in Georgia, Illinois, Nebraska, and Maryland.

    Product
    Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0954-2026·2025-12-24

    Rocket Chest Tube Catheter Procedure Trays Recalled Over Improper Securing Risk

    Rocket Medical Plc is recalling Rocket 16Fg Seldinger Catheter Procedure Trays because labeling contains misleading statements that may lead to improper device securing, creating a risk it may fall out during use.

    Product
    Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0935-2026·2025-12-24

    GE HealthCare ViewPoint 6 radiological imaging software incomplete patient history

    The Patient History tab in ViewPoint 6 ultrasound software versions 6.15.3 and 6.15.4 may not include complete patient medical history information.

    Product
    GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0949-2026·2025-12-24

    Calf Implants Recalled for Manufacturing Deviations and Lack of FDA Approval

    DSAART LLC is recalling AART Calf Implants due to manufacturing deviations from specifications and distribution without required FDA premarket approval. No injuries reported.

    Product
    Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0929-2026·2025-12-24

    Halyard surgical pack recalled for incomplete header bag seal

    AVID Medical is recalling the Halyard surgical pack due to potential incomplete sealing of the header bag, which may compromise sterility. The recall affects 90 units distributed to healthcare facilities in Georgia, Illinois, Nebraska, and Maryland.

    Product
    Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0951-2026·2025-12-24

    Rocket Seldinger Chest Catheter Recall Due to Misleading Securing Instructions

    Rocket Medical is recalling the Rocket 12Fg Seldinger Catheter with Safety Guard due to misleading labeling in device kit instructions that may result in improper securing and potential device dislodgement.

    Product
    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0942-2026·2025-12-24

    DTT Reagent for WASP Specimen Processor: Liquification Functionality Not Guaranteed

    Copan Italia is recalling DTT reagent for use with the WASP specimen processor because functionality for liquifying respiratory specimens cannot be guaranteed. Approximately 122,850 units were distributed across 14 U.S. states.

    Product
    1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0952-2026·2025-12-24

    Rocket 18Fg Chest Tube Recall: Misleading Securing Instructions

    Rocket Medical is recalling its 18Fg Seldinger Catheter Procedure Tray due to misleading instructions in device labeling that could lead to improper securing and potential device displacement.

    Product
    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied w
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0944-2026·2025-12-24

    AART Silicone Carving Implants Recalled for Specification Deviation and Missing FDA Approval

    DSAART LLC is recalling AART Silicone Carving Implants across multiple models due to manufacturing deviations from specifications and distribution without required FDA premarket approval. The recall affects 369 implants distributed to 28 U.S. states, Washington D.C., and Puerto Rico.

    Product
    Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carvi
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0950-2026·2025-12-24

    Rocket chest tube procedure tray recalled due to misleading labeling

    Rocket Medical is recalling the Rocket 12Fg Seldinger Catheter Procedure Tray (635 units) due to misleading labeling that may cause improper securing of the chest tube, risking device fall-out during use.

    Product
    Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0937-2026·2025-12-24

    Surgical Navigation Guide Contains Incorrect Instrument Compatibility Information

    SeaSpine Orthofix recalls NorthStar OCT Navigation Surgical Technique Guides due to incorrect identification of compatible Medtronic toolcards; only Solera toolcards are compatible, not Infinity toolcards.

    Product
    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0958-2026·2025-12-24

    InPen Insulin App software issue disables notification reminders after reinstall

    The InPen App for Android may fail to show notification settings when reinstalled, preventing users from enabling reminders for insulin therapy. This could cause missed insulin doses and blood sugar elevation.

    Product
    InPen App, Model/CFN Number: MMT-8061 (Android Users)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0921-2026·2025-12-24

    Medline Surgical Scissors Recalled Due to Weak Packaging Seals

    Medline Industries is recalling sterile surgical scissors with Item Number DYND04000 due to weak packaging seals that may breach sterility. If the seal fails, there is an increased risk of infection when the product is used.

    Product
    SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2026·2025-12-24

    Rocket 18Fg Seldinger Catheter safety guard labeling contains misleading statements causing improper securing

    Rocket Medical Plc is recalling the Rocket 18Fg Seldinger Catheter with Safety Guard due to misleading labeling that may result in improper securing and device displacement during use.

    Product
    Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplie
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0940-2026·2025-12-24

    MADSEN ACCUSCREEN Hearing Test Probe May Produce Inaccurate Results

    Certain MADSEN ACCUSCREEN hearing test probes may give false PASS results due to acoustic distortions from a speaker replacement. This could cause actual hearing loss to go undetected.

    Product
    MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0924-2026·2025-12-24

    Zimmer Surgical recalls Air Dermatome for control bar misalignment

    Zimmer Surgical Inc is recalling 839 units of the Zimmer Air Dermatome Model 00880100100 due to potential misalignment of the thickness control bar, which could affect proper operation during skin grafting procedures.

    Product
    Zimmer Air Dermatome, Model/Catalog Number: 00880100100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0920-2026·2025-12-24

    BeneVision Distributed Monitoring System computers may freeze or lose audio

    Mindray's BeneVision DMS workstations with specific hardware may experience audio playback failure or screen freezing, affecting patient monitoring capability.

    Product
    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2026·2025-12-24

    AVID Medical Halyard Head and Neck Tray Recalled for Incomplete Seal

    AVID Medical is recalling 56 units of the Halyard HEAD AND NECK TRAY due to a potential for incomplete seal on the header bag, which could compromise product sterility. The recall affects units distributed in Georgia, Illinois, Nebraska, and Maryland.

    Product
    Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0960-2026·2025-12-24

    Cepheid BCR-ABL Ultra diagnostic test kits recalled for inaccurate results

    Cepheid Xpert® BCR-ABL Ultra diagnostic test kits are being recalled because specimens with elevated white blood cell counts (>30,000 cells) may produce inaccurate test results. The recall affects 4,032 units distributed across the US and internationally.

    Product
    Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0927-2026·2025-12-24

    Halyard EP LAB Pack recalled for incomplete header bag seal

    AVID Medical is recalling 240 units of Halyard EP LAB Pack (Catalog ESJH009-03) due to potential incomplete seals on header bags. The affected lot was distributed to facilities in Georgia, Illinois, Nebraska, and Maryland.

    Product
    Halyard, EP LAB PK. Catalog Number: ESJH009-03.
    Category
    Medical Device
    Distribution
    4 states