The Recall Desk

State

Georgia product recalls

72,992 recalls have nationwide distribution and so reach Georgia. 9,589 additional recalls listed Georgia specifically in their distribution scope.

What the numbers show

Total
9,589
Critical
1,464
Severe
2,165
Most recent
2026-09-25

Of the 9,589 recalls naming Georgia we have scored against our rubric, 1,464 (15%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,165 (23%) are Severe.

These figures cover only the 9,589 recalls whose distribution notice names Georgia specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8426–8450 of 82581

  • HighFDA (Devices)·Z-1028-2025·2025-02-05

    AXIOS Stent Distal Tip Detachment Prevents Proper Expansion

    Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1057-2025·2025-02-05

    Karl Storz Uretero-Renoscope with Unapproved Reprocessing Instructions Recalled

    Karl Storz Endoscopy is recalling 59 units of its uretero-renoscope due to instructions for use containing reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2025·2025-02-05

    Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy

    LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.

    Product
    Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2025·2025-02-05

    Boston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment

    Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2025·2025-02-05

    CyberKnife Treatment System: Internal Snap Ring Detachment Risk

    Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.

    Product
    CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2025·2025-02-05

    Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure

    Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.

    Product
    Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2025·2025-02-05

    Karl Storz Ureteroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V056000·2025-02-05

    2025 Honda Pilot third-row seat belt may not restrain occupant

    Honda is recalling certain 2025 Pilot vehicles because the third-row passenger seat belt may not function due to incorrect routing. A non-functioning seat belt cannot properly restrain occupants, increasing injury risk during a crash.

    Product
    HONDA — HONDA PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2025·2025-02-05

    AXIOS stent delivery system outer sheath detachment prevents proper expansion

    Boston Scientific recalls 1,399 units of AXIOS stent delivery systems due to outer sheath detachment that can prevent proper device expansion, requiring procedure prolongation and device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2025·2025-02-05

    Outer Sheath Detachment in HOT AXIOS Stent Delivery System

    Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2025·2025-02-05

    AXIOS Stent Delivery System Outer Sheath May Detach During Use

    The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2025·2025-02-05

    Stent system outer sheath may detach, preventing proper expansion

    Boston Scientific's HOT AXIOS Stent has a reported defect where the outer sheath distal black tip can detach, preventing proper stent expansion and requiring device exchange.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1059-2025·2025-02-05

    Karl Storz Uretero-Renoscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz uretero-renoscope devices are being recalled because their instructions for reprocessing and sterilization have not been FDA-reviewed or approved. This poses a potential patient safety risk.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2025·2025-02-05

    AXIOS Stent and Delivery System Recalled for Improper Expansion Risk

    The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.

    Product
    AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2025·2025-02-05

    Karl Storz Ureteroscope Model 27001K Recalled for Unapproved Reprocessing Instructions

    Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2025·2025-02-05

    Karl Storz Ureteroscope recalled nationwide for unapproved reprocessing instructions

    Karl Storz Ureteroscope model 27000K is being recalled due to instructions for use containing reprocessing modalities not reviewed or approved by the FDA. The recall affects 82 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1058-2025·2025-02-05

    Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions

    Karl Storz Endoskope Uretero-Renoscope (Model 27011L) is recalled due to Instructions for Use containing reprocessing procedures that have not been FDA-reviewed or approved. The recall affects 5 units distributed nationwide.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2025·2025-02-05

    AXIOS Stent Delivery System: Detaching Outer Sheath May Prevent Stent Expansion

    Boston Scientific is recalling 1,144 AXIOS Stent Delivery System units because the outer sheath's distal black tip can detach. If this occurs, the tip may remain around the stent saddle and prevent proper stent expansion, requiring device exchange.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2025·2025-02-05

    Alphatec Calibrate CCX Interbody Implants Recalled for Post-Operative Collapse

    Alphatec Spine is recalling Calibrate CCX spinal implants used in fusion procedures after receiving complaints of post-operative implant collapse. Approximately 1,511 implants were distributed nationwide.

    Product
    Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0212-2025·2025-02-05

    Duloxetine Delayed-Release Capsules recalled nationwide for nitrosamine impurity

    Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2025·2025-02-05

    BD Pyxis MedStation Door Latch Assembly Failures in Automated Dispensing Cabinets

    The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.

    Product
    BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized he
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-1064-2025·2025-02-05

    Karl Storz Ureteroscope Recalled for Unapproved Reprocessing Instructions

    Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1069-2025·2025-02-05

    Bedside cardiac monitor system recalled for display distortion

    The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2025·2025-02-05

    Karl Storz Uretero-Renoscope recalled for unapproved reprocessing instructions

    Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.

    Product
    KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2025·2025-02-05

    HOT AXIOS Stent Delivery System Outer Sheath May Detach, Preventing Stent Expansion

    Boston Scientific's HOT AXIOS stent delivery system has a defect where the outer sheath can detach and prevent proper stent expansion, requiring device replacement.

    Product
    HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
    Category
    Medical Device
    Distribution
    Distributed nationwide