The Recall Desk

State

Florida product recalls

73,092 recalls have nationwide distribution and so reach Florida. 12,854 additional recalls listed Florida specifically in their distribution scope.

What the numbers show

Total
12,854
Critical
1,775
Severe
2,990
Most recent
2026-09-25

Of the 12,854 recalls naming Florida we have scored against our rubric, 1,775 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,990 (23%) are Severe.

Which agencies issued them

These figures cover only the 12,854 recalls whose distribution notice names Florida specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8426–8450 of 85946

  • HighFDA (Devices)·Z-1185-2025·2025-02-26

    Radiation Therapy Planning Software Correction for Density Uncertainty in Dose Calculations

    RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations within dose planning functions affecting proton and light ion treatments in versions 4.5 through 2024B.

    Product
    Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1181-2025·2025-02-26

    AnchorFast Guard Endotracheal Tube Fasteners Recalled Due to Tube Migration Risk

    Hollister is recalling AnchorFast Guard endotracheal tube fasteners because decreased skin barrier wear time could cause tube migration. The recall affects multiple lot numbers distributed in the US and Canada.

    Product
    AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2025·2025-02-26

    Medical Device RayStation Dosage Calculation Inconsistency in Radiation Therapy Planning

    RayStation radiation therapy treatment planning software contains an inconsistency in how it handles density uncertainty during dose calculations for proton and light ion treatments, potentially affecting treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2025·2025-02-26

    Dexcom G6 glucose receiver may fail to deliver high or low alarms

    Under rare conditions, the Dexcom G6 receiver may fail to send high or low glucose alarms due to a software error, potentially delaying detection of dangerous blood sugar levels.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2025·2025-02-26

    3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.

    Product
    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2025·2025-02-26

    Dexcom G6 Glucose Monitor May Fail to Deliver Alarms Properly

    Dexcom G6 continuous glucose monitors may fail to deliver high or low blood sugar alarms due to a software error, potentially delaying detection of dangerous glucose levels. Alarms will be delayed and skip in sequence until the device is reset.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1190-2025·2025-02-26

    RayStation radiation therapy software: incorrect density uncertainty calculations in dose planning

    RayStation radiation therapy planning software versions 4.5 through 2024B contains an inconsistency in density uncertainty calculations affecting proton and light ion dose computations. No illnesses reported.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2025·2025-02-26

    Endotracheal Tube Fastener Recalled for Decreased Skin Barrier Wear

    Hollister is recalling AnchorFast Oral Endotracheal Tube Fasteners due to reports of decreased skin barrier wear time, which could lead to tube migration. The recall affects approximately 366,324 units distributed in the US and Canada.

    Product
    AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2025·2025-02-26

    Endotracheal Tube Fastener Recalled for Potential Tube Migration Risk

    Hollister is recalling AnchorFast SlimFit oral endotracheal tube fasteners worldwide due to decreased skin barrier wear time that could lead to tube migration.

    Product
    AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2025·2025-02-26

    Radiation Therapy Planning System Density Calculation Inconsistency in RayStation

    RayStation radiation therapy planning software versions 4.5 through 2024B contain an inconsistency in how density uncertainty is handled in dose calculation functions for proton and light ion therapy plans.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0243-2025·2025-02-26

    Atomoxetine Capsules Recalled Due to N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling approximately 58,416 bottles of Atomoxetine 80 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. This is a Class II recall.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1204-2025·2025-02-26

    Dexcom G6 Glucose Monitoring System Receiver May Fail to Deliver Critical Alarms

    The Dexcom G6 receiver may rarely fail to deliver or delay glucose alarms due to a software error, potentially missing dangerous blood sugar events. No illnesses have been reported.

    Product
    Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2025·2025-02-26

    RayStation Radiation Therapy Software Recalled for Dose Calculation Inconsistency

    RayStation radiation therapy planning software is being recalled due to inconsistent handling of density uncertainty in dose calculations for proton and light ion treatment plans. The software defect may affect the accuracy of calculated radiation doses.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0226-2025·2025-02-26

    Lorazepam Tablets Recalled Due to Sub-Potency and Failed Stability Testing

    The Harvard Drug Group is recalling Lorazepam Tablets USP 0.5mg due to sub-potency and failed stability test results. Approximately 82,281 cartons are affected nationwide and in Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty computational defect

    RayStation treatment planning software versions 4.5 through 2024B may incorrectly handle density uncertainty in radiation dose calculations for proton and light ion therapy. An inconsistency in three key functions could affect treatment planning accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2025·2025-02-26

    Irix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates

    XTANT Medical Holdings is recalling Irix-A Lumbar Fusion System implants due to incorrect expiration date labeling on sterile spacers. Fourteen units were distributed in Arizona, California, Colorado, Louisiana, Ohio, Texas, West Virginia, and Australia.

    Product
    Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE))
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2025·2025-02-26

    3M V.A.C. VIA Negative Pressure Wound Therapy System Recalled for Leak Alarm Malfunctions

    KCI USA is recalling approximately 2,169 units of the 3M V.A.C. VIA negative pressure wound therapy system due to increased complaints about leak alarm malfunctions affecting certain units.

    Product
    3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2025·2025-02-26

    RayStation radiation therapy planning software density uncertainty calculation inconsistency

    RayStation radiation therapy planning software contains an inconsistency in density uncertainty calculations affecting robust optimization and dose computation functions for proton and light ion treatment plans.

    Product
    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0233-2025·2025-02-26

    Prescription Atomoxetine capsules recalled for N-Nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 25 mg capsules nationwide due to the presence of N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 175,920 bottles are affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0241-2025·2025-02-26

    Atomoxetine 40 mg Capsules Recalled for N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals is recalling 233,040 bottles of Atomoxetine 40 mg capsules nationwide due to N-Nitroso impurity above FDA safety limits. Patients should check their medication bottles and contact their healthcare provider.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0242-2025·2025-02-26

    Atomoxetine Capsules Recalled for Manufacturing Impurity Above Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine Capsules, 60 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. Approximately 53,952 bottles were distributed nationwide.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0244-2025·2025-02-26

    Atomoxetine Prescription Capsules Recalled for Impurity Above FDA Recommended Level

    Glenmark Pharmaceuticals is recalling 58,368 bottles of Atomoxetine Capsules 100 mg due to N-Nitroso Atomoxetine impurity above FDA-recommended limits. The recall affects bottles distributed nationwide.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0232-2025·2025-02-26

    Atomoxetine Capsules Recalled for N-Nitroso Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling Atomoxetine capsules due to N-Nitroso impurity levels exceeding FDA recommended limits. The recall affects 56,208 bottles nationwide with specific lot numbers.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide