The Recall Desk

State

Colorado product recalls

72,992 recalls have nationwide distribution and so reach Colorado. 6,941 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,941
Critical
1,218
Severe
1,507
Most recent
2026-09-09

Of the 6,941 recalls naming Colorado we have scored against our rubric, 1,218 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,507 (22%) are Severe.

These figures cover only the 6,941 recalls whose distribution notice names Colorado specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7901–7925 of 79933

  • HighFDA (Drugs)·D-0228-2025·2025-02-26

    Lorazepam tablets recalled due to failed potency and impurity specifications

    The Harvard Drug Group LLC is recalling Lorazepam 2mg tablets due to out-of-specification results in potency and impurity testing. Affected products were distributed nationwide.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    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 (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 (Drugs)·D-0227-2025·2025-02-26

    Lorazepam Tablets Recalled for Failed Impurity and Potency Specifications

    The FDA is recalling 94,349 cartons of Lorazepam 1mg tablets due to out-of-specification results for impurities and sub-potency discovered during routine stability testing. The affected product was distributed nationwide in the U.S. and Puerto Rico.

    Product
    LORAZEPAM — LORAZEPAM (LORAZEPAM)
    Category
    Drug
    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-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-1199-2025·2025-02-26

    Patient Warming Mattress Recalled for Cable Connection Defect

    Augustine Temperature Management recalls 3 Hot Dog patient warming mattresses (US530) due to cable connector deflection that may cause intermittent connection failure, potentially occurring after one year of use.

    Product
    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2025·2025-02-26

    RayStation radiation therapy software recall for density calculation inconsistency

    RayStation treatment planning software versions 4.5-2024B contain a calculation error in density uncertainty functions affecting proton and light ion treatment plans. The error could lead to incorrect dose calculations.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2025·2025-02-26

    Hot Dog Patient Warming Mattress Connector Cable Deflection Recall

    Augustine Temperature Management is recalling 4 units of the Hot Dog Patient Warming Mattress due to connector cable deflection that causes intermittent connection failures after approximately one year of use.

    Product
    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
    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 (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-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-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 (Drugs)·D-0234-2025·2025-02-26

    Atomoxetine capsules recalled due to elevated N-nitroso impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 40 mg capsules nationwide due to manufacturing deviations. Some lots contain N-nitroso Atomoxetine impurity above FDA-recommended limits.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    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 (Drugs)·D-0236-2025·2025-02-26

    Atomoxetine 80 mg Capsules Recalled for N-Nitroso Impurity Contamination

    Glenmark Pharmaceuticals is recalling 87,600 bottles of Atomoxetine 80 mg capsules nationwide due to N-Nitroso Atomoxetine impurity detected above FDA-recommended limits. Consult your healthcare provider if affected.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0566-2025·2025-02-26

    Feel Good Foods Three Cheese Mac & Cheese Bites recalled due to metal pieces

    Feel Good Foods Three Cheese Mac & Cheese Bites are being recalled nationwide due to the presence of metal pieces in the frozen product. Metal fragments pose a potential choking or injury hazard.

    Product
    Feel Good Foods; Three Cheese Mac & Cheese Bites; NET WT 8oz (224g); packaged in yellow carton; 9 units per case; Frozen; UPC: 89903900280-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0568-2025·2025-02-26

    AAHU BARAH brand Soft Plum recalled for undeclared sulfites

    AAHU BARAH brand Soft Plum is being recalled due to undeclared sulfites in the product. Consumers sensitive to sulfites should not consume this product and should return it to the point of purchase.

    Product
    AAHU BARAH brand SOFT PLUM; NET WT. 0.5 LB; Import By: AAHU BARAH USA, INC.; Soft Plum Aloo Bukahara 1/2 LB; *May Contain Sulfites As preservatives; UPC 882475049186; packaged in clear plastic bags.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1191-2025·2025-02-26

    RayStation Radiation Therapy Planning Software Recall for Density Calculation Inconsistency

    RayStation radiation therapy planning software contains an inconsistency in how it calculates density uncertainty for proton and light ion treatments. This affects versions 4.5 through 2024B and could impact treatment plan accuracy.

    Product
    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
    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-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 (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 (Drugs)·D-0240-2025·2025-02-26

    Prescription Drug Recall: Atomoxetine Capsules Due to Impurity

    Glenmark Pharmaceuticals is recalling Atomoxetine 25mg capsules nationwide due to manufacturing deviations resulting in N-Nitroso Atomoxetine impurity above FDA limits. Consumers should contact their healthcare provider or pharmacist.

    Product
    ATOMOXETINE — ATOMOXETINE (ATOMOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0238-2025·2025-02-26

    Atomoxetine Capsules Recalled for Chemical Impurity Above FDA Limits

    Glenmark Pharmaceuticals is recalling 120,000 bottles of Atomoxetine 10 mg capsules nationwide due to N-nitroso Atomoxetine impurity exceeding FDA recommended limits. Multiple lot numbers are affected with expiration dates through July 2026.

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