The Recall Desk

State

Colorado product recalls

72,820 recalls have nationwide distribution and so reach Colorado. 6,938 additional recalls listed Colorado specifically in their distribution scope.

What the numbers show

Total
6,938
Critical
1,218
Severe
1,506
Most recent
2026-09-02

Of the 6,938 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 1,506 (22%) are Severe.

These figures cover only the 6,938 recalls whose distribution notice names Colorado specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

551–575 of 79758

  • HighFDA (Devices)·Z-2778-2026·2026-07-29

    MiniMed Go App Recalled Due to Missed Insulin Alerts

    Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.

    Product
    MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0710-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns

    Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (125 mcg) because the medication may be subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2026·2026-07-29

    3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements

    PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2777-2026·2026-07-29

    Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates

    Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.

    Product
    Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0716-2026·2026-07-29

    Rohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Max Strength because there is a lack of assurance regarding the product's sterility.

    Product
    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, NDC 10742-8158-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material Issues

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. ROBOTIC CDS980523M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2026·2026-07-29

    Olympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.

    Product
    Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2769-2026·2026-07-29

    Silent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance

    Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.

    Product
    Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0712-2026·2026-07-29

    FDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test

    Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0736-2026·2026-07-29

    Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories

    Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0725-2026·2026-07-29

    Glycopyrrolate Injection Recall Due to Hair Contamination

    Fresenius Kabi is recalling Glycopyrrolate Injection due to the presence of particulate matter, specifically hair found in the product.

    Product
    GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2761-2026·2026-07-29

    Olympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults

    Olympus Corporation of the Americas is recalling 10 Olympus 4K UHD LCD Monitors (Model OEV321UH) because the HDMI and DisplayPort connectors may become faulty.

    Product
    Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0729-2026·2026-07-29

    FDA Recalls Xylocaine Injections Due to Hair Contamination

    FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0735-2026·2026-07-29

    Dabigatran Etexilate Capsules Recalled Over Impurity Test Failure

    Ascend Laboratories is recalling 1,753 cartons of dabigatran etexilate capsules (lot 25141707) due to out-of-specification results in impurity testing during 12-month stability studies.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2675-2026·2026-07-29

    BOSS Xe Family Aiming Devices Recalled for Software Safety Enhancement

    Wilcox Industries Corp. is recalling BOSS Xe family aiming devices to implement a software enhancement designed to increase safety.

    Product
    The intended use is to be paired with a weapon for aiming purposes.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2775-2026·2026-07-29

    SnapshotGLO Wound Imaging Device Recalled Due to Battery Charging Software Issue

    Kent Imaging, Inc. is recalling SnapshotGLO Wound Imaging Devices (Models KB100 and KB100AA) because software issues may prevent the device from recharging.

    Product
    SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0724-2026·2026-07-29

    Cyproheptadine Hydrochloride Syrup Recall Due to Precipitate

    Rising Pharma is recalling cyproheptadine hydrochloride syrup due to the presence of precipitate, including crystallization and floating particles in the bottle.

    Product
    CYPROHEPTADINE HYDROCHLORIDE — CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide