The Recall Desk

State

Colorado product recalls

72,913 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 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2001–2025 of 79854

  • ModerateFDA (Devices)·Z-2083-2026·2026-05-13

    One Step UTI in vitro diagnostic test recalled for missing FDA approval

    DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step UTI in vitro diagnostic test REF: 3374
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Safety Corrective Action Recall

    Katalyst Surgical is recalling DEX Ophthalmic Tissue Forceps, 25ga Model DVF4016-25-S due to a field safety corrective action for instructions for use (IFU). The recall affects 90 units distributed nationwide in the US and internationally.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0520-2026·2026-05-13

    Enalapril Maleate 20 mg tablets recalled for out-of-specification impurities

    JB Chemicals and Pharmaceuticals Ltd is recalling Enalapril Maleate 20 mg tablets nationwide due to out-of-specification results in organic impurities testing. Affected lot GEH25023 was distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2074-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps recalled for instruction updates

    Katalyst Surgical is issuing a Field Safety Corrective Action for 670 units of DEX Ophthalmic Tissue Forceps (Model DVF4019-25) due to updates required in the instructions for use. The device was distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries has recalled 6,676 units of multiple Medline Convenience Kits used in gynecological and other surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance.

    Product
    Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Mo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2122-2026·2026-05-13

    Medline Convenience Kits sterilization calibration issue recalled

    Medline is recalling Convenience Kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2120-2026·2026-05-13

    Medline Burn Care Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling three burn care convenience kits because calibration issues with sterilization and packaging equipment could compromise their sterility assurance level.

    Product
    Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0514-2026·2026-05-13

    Duloxetine Delayed-Release Capsules Recalled for Impurity Above Limit

    Ajanta Pharma Ltd. is recalling Duloxetine Delayed-Release Capsules nationwide because the active ingredient contains N-nitroso-Duloxetine impurity above the FDA-recommended limit of 0.83 ppm.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2084-2026·2026-05-13

    One Step pH In Vitro Diagnostic Test Recalled Without FDA Clearance

    DFI Co., Ltd. is recalling the One Step pH in vitro diagnostic test because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step pH in vitro diagnostic test REF: 31I4P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps instructions for use correction

    Katalyst Surgical is issuing a corrective action for instructions in DEX Ophthalmic Tissue Forceps (Model DVF4014-25-S). The recall affects 80 units distributed worldwide including the US and Peru, Argentina, South Korea, Japan, and France.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps subject to IFU corrective action

    Katalyst Surgical is issuing a field safety corrective action for instructions for use (IFU) in DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH (Model DVF4005-25).

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Model DVF4034-25 Instruction Recall

    Katalyst Surgical, LLC is correcting instructions for DEX Ophthalmic Tissue Forceps, Model DVF4034-25. The company has issued a field safety corrective action for the product's instructions for use.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0695-2026·2026-05-13

    SunRidge Farms Organic Black Beans Recalled Due to Potential Pesticide Contamination

    Falcon Trading Co., Inc. is recalling SunRidge Farms Organic Black Beans due to potential contamination with the pesticides haloxyfop and thiamethoxam.

    Product
    SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA EXPORTADOR: ESPAR SRL FECHA PRODUCCION: 11/13/2023 Item: 003040 UPC: 086700930403
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2077-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Require Corrective Instructions Update

    Katalyst Surgical is correcting instructions for DEX Ophthalmic Tissue Forceps (Model DVF4022-25-S) due to a field safety issue related to the Instructions for Use (IFU).

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps subject to Field Safety Corrective Action

    Katalyst Surgical, LLC is issuing a Field Safety Corrective Action for instructions for use (IFU) related to DEX Ophthalmic Tissue Forceps (Model DVF4005-23). The corrective action addresses a labeling issue in the product instructions.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2026·2026-05-13

    Medline Surgical Gowns Sterilization Calibration Issues

    Medline Industries has recalled multiple lots of surgical gowns due to calibration issues with sterilization and packaging equipment that may affect the sterility assurance level of the products.

    Product
    See complete list in RES, exceeds character limit. Medline Surgical Gowns
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps Field Safety Corrective Action Notice

    Katalyst Surgical is issuing a field safety corrective action for DEX Ophthalmic Tissue Forceps (Model DVF4019-25-S) due to instructions for use updates. The recall affects 645 units distributed nationwide in the US and internationally.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2079-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps recalled for instructions update

    Katalyst Surgical is issuing a Field Safety Corrective Action for DEX Ophthalmic Tissue Forceps (Model DVF4034-25-S) due to instructions-for-use (IFU) corrections needed.

    Product
    DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0522-2026·2026-05-13

    Duloxetine delayed-release capsules recalled for N-nitroso impurity contamination

    Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg due to the presence of N-nitroso-duloxetine impurity above FDA recommended limits. The affected product was distributed nationwide.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2076-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps require instructions-for-use correction

    Katalyst Surgical is correcting the instructions for use (IFU) for DEX Ophthalmic Tissue Forceps (Model DVF4019-27) and related scissors due to a field safety issue.

    Product
    DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2026·2026-05-13

    Medline Convenience Kits recalled due to sterilization calibration issues

    Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2073-2026·2026-05-13

    DEX Ophthalmic Tissue Forceps 23ga Maculorhexis Forceps Recalled

    Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, Model DVF4019-23, due to a field safety corrective action for instructions for use in DEX Forceps and Scissors. The device is distributed worldwide.

    Product
    DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2026·2026-05-13

    Medline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries has recalled multiple surgical convenience kits after discovering calibration issues with sterilization equipment that may impact the sterility assurance level of the devices. The kits include robotic surgery, gynecology, urology, and general surgical packs distributed nationwide.

    Product
    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0516-2026·2026-05-13

    Duloxetine Delayed-Release Capsules 20 mg Recalled for Impurity

    Ajanta Pharma USA Inc. is recalling Duloxetine 20 mg delayed-release capsules (Lot PA10734, expiration June 2026) because they contain elevated levels of N-nitroso-Duloxetine impurity above the FDA-recommended limit.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2026·2026-05-13

    Medline Surgical Packs recalled due to sterilization equipment calibration issues

    Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.

    Product
    Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
    Category
    Medical Device
    Distribution
    Distributed nationwide